Sanofi US News

• New WAYRILZ^® (rilzabrutinib) data to feature impact on quality of life in ITP, phase 2 wAIHA clinical outcomes, and phase 3 trial design
• Additional SARCLISA^® (isatuximab) analyses highlight subcutaneous administration via investigational OBI for treatment in MM
• Clinical data and real-world evidence underscore the potential of ALTUVIIIO^® [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl] and QFITLIA^® (fitusiran) to help address unmet needs for people living with hemophilia  

Cambridge, MA, November 4, 2025. New data from 50 abstracts highlighting Sanofi’s commitment to advancing care across rare diseases, blood cancers, and transplants will be showcased at the 67th American Society of Hematology (ASH) Annual Meeting & Exposition, in Orlando, Florida.

“Our presentations at ASH reinforce how we are elevating the patient treatment experience to move beyond the limits of conventional medicines in rare diseases and blood cancers,” said Chris Corsico, MD, MPH, Global Head of Development at Sanofi. “We look forward to expanding the body of evidence supporting approved therapies for hemophilia and immune thrombocytopenia and exploring the potential of multi-immune modulation to help address unmet medical needs in other diseases. Additionally, new data evaluating SARCLISA in both the frontline setting and administered subcutaneously with an innovative on-body injector demonstrates its potential utility across the multiple myeloma care continuum.” 

Presentations covering hemophilia and other conditions of complex immune dysregulation, such as immune thrombocytopenia (ITP), will underscore continued advancements in clinical and quality-of-life outcomes for patients. In multiple myeloma (MM), new analyses evaluating the investigational subcutaneous (SC) formulation of SARCLISA administered via an on-body injector (OBI) will inform the potential role of this innovative delivery method to advance patient care and experience. Other data include findings in the newly diagnosed and relapsed settings. New data assessing the response dynamics to REZUROCK^® (belumosudil) in chronic graft-versus-host disease (cGVHD) will also be featured. ASH will also feature presentations on AYVAKIT^® (avapritinib) by Blueprint Medicines, a Sanofi company, highlighting long-term data across the spectrum of systemic mastocytosis (SM), including indolent and advanced SM.

Notable presentations across disease areas will be shared and the data include:

Rare diseases
New findings from clinical and real-world studies on ALTUVIIIO, QFITLIA and WAYRILZ will be presented, including long-term extension data, a subgroup analysis, and exploratory endpoint. Additional data abstracts will explore the investigational use of rilzabrutinib in warm autoimmune hemolytic anemia (wAIHA) and sickle cell disease (SCD), evaluating the potential of multi-immune modulation in these conditions.

ITP

• LUNA 3 phase 3 study (clinical study identifier: NCT04562766): new analyses of the impact of WAYRILZ on health-related quality of life and bleeding scores, reduction in corticosteroid use and reproductive health in people with ITP.
• LUNA 4 phase 3b study (clinical study identifier: NCT07007962): study design details aimed to assess earlier use of WAYRILZ to address the underlying immune dysregulation in ITP following first-line treatment failure.

Hemophilia

• SWITCH phase 1 study (clinical study identifier: NCT06145373): real-world study protocol and rationale for evaluating outcomes in patients switching to QFITLIA from emicizumab.
• XTEND-ed phase 3 study (clinical study identifier: NCT04644575): additional analysis evaluating the efficacy and safety profile of ALTUVIIIO in adult and pediatric patients with severe hemophilia A.
• Real-world analysis assessing the treatment experience with ALTUVIIIO in people with hemophilia A.

wAIHA

• LUMINA phase 2b study (clinical study identifier: NCT05002777): 74-week results evaluating long-term efficacy and safety of WAYRILZ in patients with wAIHA.

SCD

• LIBRA phase 3 study (clinical study identifier: NCT06975865): study design details aimed to assess the potential of WAYRILZ to reduce vaso-occlusive crises (VOC) and improve outcomes for children and adults living with SCD.

The safety and efficacy of WAYRILZ, QFITLIA and ALTUVIIIO have not been evaluated by any regulatory authority outside of their approved indications.

Oncology
New data evaluating the use of SARCLISA across the MM care continuum, including investigational data on subcutaneous administration and in newly diagnosed MM (NDMM), will also be highlighted. AYVAKIT data will highlight long-term survival outcomes for patients with advanced SM, including in the first-line treatment setting.

• IRAKLIA phase 3 study (clinical study identifier: NCT05405166): new analyses evaluating SARCLISA SC administered via an OBI, including home administration, and impact of bodyweight on pharmacokinetics and clinical outcomes.
• IMROZ phase 3 study (clinical study identifier: NCT03319667): pooled analysis evaluating the safety and efficacy of SARCLISA in combination with bortezomib, lenalidomide and dexamethasone (VRd) in both frail and non-frail elderly adults with transplant-ineligible NDMM.
• GMMG-HD7 phase 3 study (clinical study identifier: NCT03617731): new results from part one evaluating health-related quality of life in transplant-eligible NDMM patients treated with SARCLISA-RVd.
• BENEFIT phase 3 study (clinical study identifier: NCT04751877): results evaluating long-term rates of minimal residual disease (MRD) negativity across standard and high-risk transplant-ineligible NDMM patients treated with SARCLISA-VRd.
• PATHFINDER (clinical study identifier: NCT03580655): new results examining four-year safety, efficacy and bone health data of AYVAKIT in the treatment of advanced SM, and additional analyses showing the therapy’s effects on skin lesions.

The safety and efficacy of SARCLISA have not been evaluated by any regulatory authority outside of its approved indications and methods of delivery.

The safety and efficacy of AYVAKIT have not been evaluated by any regulatory authority outside of its approved indications.

Transplant
New analyses offering further insight into the response dynamics with REZUROCK in hematologic transplant and cGVHD will be featured.

The safety and efficacy of REZUROCK have not been evaluated by any regulatory authority outside of its approved indications.

A full list of abstracts and presentations across the portfolios can be found below.

Presenting author	Abstract title	Presentation
Immune thrombocytopenia
Cooper	Improved Health-Related Quality of Life and Bleeding Scores with Oral Bruton Tyrosine Kinase Inhibitor Rilzabrutinib in the Open-Label Period of the Multicenter Phase 3 LUNA 3 Study in Adults with Immune Thrombocytopenia	Abstract #1254 Poster Presentation December 6, 2025 5:30 PM - 7:30 PM
Kuter	Reduction in Corticosteroid Use with Rilzabrutinib and Sustained Response in Adults with Persistent/Chronic Immune Thrombocytopenia in the Long-Term Extension Period of the Phase 3 LUNA3 Study	Abstract #1260 Poster Presentation December 6, 2025 5:30 PM - 7:30 PM
Lambert	Reproductive Health in Patients with Primary Immune Thrombocytopenia Receiving Rilzabrutinib: A Subgroup Analysis from the Phase 3 LUNA3 Multicenter Study	Abstract #3027 Poster Presentation December 7, 2025 6:00 PM - 8:00 PM
Kuter	Early Multi-Immune Modulation with Rilzabrutinib in Patients with Primary ITP after First Line Treatment Failure: A Phase 3b Study (LUNA 4)	Abstract #4827 Poster Presentation December 8, 2025 6:00 PM - 8:00 PM
Hemophilia A
Malec	Clinical Outcomes up to 4 Years of Once-Weekly Efanesoctocog Alfa Prophylaxis in Previously Treated Adults, Adolescents, and Children with Severe Hemophilia A: Interim Analysis of the Phase 3 XTEND-ed Long-Term Extension Study	Abstract #539 Oral Presentation December 7, 2025 1:00 PM – 1:15 PM
Zaheer	Real-world Experience of Efanesoctocog Alfa in Hemophilia A Patients in the US: A Retrospective Analysis	Abstract #1286 Poster Presentation December 6, 2025 5:30 PM - 7:30 PM
Kragh	Understanding Unmet Needs for People with Haemophilia A Receiving Factor and Non-Factor Treatments	Abstract #2679 Poster Presentation December 6, 2025 5:30 PM - 7:30 PM
Dumont	Patient Characteristics, Treatment Patterns, and Bleeding in Patients with Hemophilia A without Inhibitors Initiating Efanesoctocog Alfa in the US: An Administrative Claims Analysis	Abstract #1290 Poster Presentation December 6, 2025 5:30 PM - 7:30 PM
Janbain	Quality of Life and Functional Improvements with Efanesoctocog Alfa in Patients with Moderate-to-Severe Hemophilia A: A Real-World Survey	Abstract #4846 Poster Presentation December 8, 2025 6:00 PM - 8:00 PM
Hemophilia A and B
Simpson	High Treatment Compliance and Tolerability with Fitusiran Antithrombin-Based Dose Regimen in People with Hemophilia A or B, with or without Inhibitors: ATLAS-OLE Study	Abstract #1298 Poster Presentation December 6, 2025 5:30 PM - 7:30 PM
Young	Evaluating the Safety and Tolerability of Switching from Emicizumab to Fitusiran Prophylaxis in Adult Males with Severe Hemophilia A, with or without Inhibitors: SWITCH Study, a Trial in Progress	Abstract #3076 Poster Presentation December 7, 2025 6:00 PM - 8:00 PM
Pipe	Experience with Minor Surgeries in People with Hemophilia A or B with and without Inhibitors Receiving Fitusiran	Abstract #4850 Poster Presentation December 8, 2025 6:00 PM - 8:00 PM
Warm autoimmune hemolytic anemia
Kuter	Phase 3 Study to Evaluate the Efficacy and Safety of Rilzabrutinib in Primary Warm Autoimmune Hemolytic Anemia: LUMINA 3 Study Design	Abstract #1123 Poster Presentation December 6, 2025  5:30 PM - 7:30 PM
Kuter	Fatigue, Hemoglobin, and Inflammatory Markers in Warm Autoimmune Hemolytic Anemia: Analysis from a Phase 2b Trial of Rilzabrutinib (LUMINA2)	Abstract #1105 Poster Presentation December 6, 2025 5:30 PM - 7:30 PM
Fattizzo	Long-Term Efficacy and Safety of Rilzabrutinib, an Oral Bruton Tyrosine Kinase Inhibitor in Patients with Warm Autoimmune Hemolytic Anemia in the LUMINA Phase 2b Part B study: A 74-Week Follow-Up	Abstract #4655 Poster Presentation December 8, 2025 6:00 PM - 8:00 PM
Sickle cell disease
Ataga	A Randomized, Double-Blind, Placebo-Controlled Trial of a Novel BTK Inhibitor (rilzabrutinib) in Patients with Sickle Cell Disease Aged 10–65 years: LIBRA Study	Abstract #2975 Poster Presentation December 7, 2025 6:00 PM - 8:00 PM
Multiple myeloma
Ramasamy	Double Hit Ultra-High Risk Myeloma Treated with Isatuximab, Bortezomib, Lenalidomide, Dexamethasone and Cyclophosphamide (Isa-VRDc) Induction and Isa-VRD Consolidation: Initial Results of the UK Myeloma Research Alliance RADAR Trial in Newly Diagnosed Transplant Eligible Patients	Abstract #98 Oral Presentation December 6, 2025  9:45 AM – 10:00 AM
Bobin	Sustained Minimal Residual Disease Negativity in Transplant Ineligible Newly Diagnosed Multiple Myeloma Treated with Isatuximab Plus Lenalidomide and Dexamethasone with Bortezomib (Isa-VRd) Versus Isa-RD: 12-24-Month Data from the Phase 3 BENEFIT Trial (IFM 2020-05)	Abstract #368 Oral Presentation December 6, 2025 4:15 PM – 4:30 PM
Schavgoulidze	Longitudinal Assessments of Minimal Residual Disease in High-risk Patients from BENEFIT Phase 3 Randomized Study of Isatuximab plus Lenalidomide and Dexamethasone with Bortezomib (Isa-VRd) Versus IsaRd in Newly Diagnosed Transplant Ineligible Multiple Myeloma (IFM 2020-05)	Abstract #497 Oral Presentation December 7, 2025 10:30 AM – 10:45 AM
Chalayer	Apixaban Pharmacokinetics in Newly Diagnosed Multiple Myeloma Patients Treated in the BENEFIT and ISASOCUT Trials: The Apixabro/Mibapix Study	Abstract #744 Oral Presentation December 8, 2025 11:45 AM – 12:00 PM
Jin	Peripheral Residual Disease Activity Assessment by MALDI-TOF Mass Spectrometry in Patients with Newly-Diagnosed Multiple Myeloma in the GMMG-HD7 Study	Abstract #920 Oral Presentation December 8, 2025 3:00 PM – 3:15 PM
Ocio	Efficacy and Safety of Isa-VRd in Elderly Patients with or without Frailty Criteria: Pooled Analysis of IMROZ and Phase 1b Studies in Newly Diagnosed Multiple Myeloma Patients	Abstract #2267 Poster Presentation December 6, 2025 5:30 PM - 7:30 PM
Bonifay	Clonotypic Peptide Mass Spectrometry to Monitor M-Protein Reduction in Patients with Relapsed/Refractory Multiple Myeloma from IKEMA Study	Abstract #2268 Poster Presentation December 6, 2025 5:30 PM - 7:30 PM
Mai	Health-Related Quality of Life in Patients with Newly Diagnosed Multiple Myeloma Eligible for Transplantation and Treated with Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone (Isa-RVd) Versus RVd Alone: Results from Part 1 of the GMMG-HD7 Study	Abstract #2263 Poster Presentation December 6, 2025 5:30 PM - 7:30 PM
Ludwig	Randomized Comparison Between Isatuximab-Rd and Rd Induction, Followed by Isa-R or R Maintenance in Very Elderly Patients with NDMM: Efficacy Data on MRD After Induction (AGMT-MM04 Trial)	Abstract #2258 Poster Presentation December 6, 2025 5:30 PM - 7:30 PM
Askeland	Steroid-Toxicity in Patients with Newly Diagnosed Multiple Myeloma Treated with a Limited Dexamethasone Regimen; Results from the NMSG REST Study	Abstract #2785 Poster Presentation December 6, 2025 5:30 PM - 7:30 PM
Hudson-Lund	Long-Read RNA Sequencing of First Multiple Myeloma Patient Cohort Reveals Landscape of Variant Expression in Newly Diagnosed Patients from the UKMRA RADAR Trial	Abstract #2141 Poster Presentation December 6, 2025 5:30 PM – 7:30 PM
Mateos	Home Administration of Isatuximab Subcutaneous by On-Body Injector in Relapsed/Refractory Multiple Myeloma in the Phase 3 IRAKLIA Study	Abstract #4044 Poster Presentation December 7, 2025 6:00 PM - 8:00 PM
Terpos	Isatuximab with Bortezomib, Cyclophosphamide, and Dexamethasone Followed by Isatuximab and Lenalidomide Maintenance in Newly Diagnosed Multiple Myeloma Patients with Severe Renal Impairment: Final Analysis of a Phase 2 Study by the Greek Myeloma Study Group	Abstract #4036 Poster Presentation December 7, 2025 6:00 PM - 8:00 PM
Terpos	Response-Adapted Randomization to Q2W vs Q4W Isatuximab Beyond Cycle 6 in Relapsed MM: Results from a Phase 2 Study of Isa-Pd in Lenalidomide- and PI-Exposed Patients	Abstract #4037 Poster Presentation December 7, 2025 6:00 PM - 8:00 PM
Martinet	Single-Cell Immune Landscape Associated with Isatuximab, Carfilzomib, Lenalidomide, and Dexamethasone Induction Efficacy in Newly Diagnosed Myeloma	Abstract #3932 Poster Presentation December 7, 2025 6:00 PM – 8:00 PM
O’Gorman	Isatuximab Plus Lenalidomide, Bortezomib, and Dexamethasone (Isa-RVd) as Induction Therapy in Transplant-Eligible Patients with Newly Diagnosed Multiple Myeloma: Primary Analysis of Parallel Phase 2 Studies by the Dana-Farber Cancer Institute and Cancer Trials Ireland	Abstract #4030 Poster Presentation December 7, 2025 6:00 PM – 8:00 PM
Lin	Shifting First-Line Paradigms: Real-World Treatment Outcomes and Healthcare Burden in Non-Transplant Newly Diagnosed Multiple Myeloma in France (2015-2022)	Abstract #6353 Poster Presentation December 8, 2025 6:00 PM - 8:00 PM
Lin	Real-World Treatment Patterns and Outcomes in Frail and Non-Frail Patients with Newly Diagnosed Multiple Myeloma Not Undergoing Frontline Transplant: A Study Using COTA Oncology Database	Abstract #6352 Poster Presentation December 8, 2025 6:00 PM – 8:00 PM
Dou	Isatuximab Subcutaneous via an On-Body Injector vs Isa Intravenous, Plus Pomalidomide and Dexamethasone (Pd) in Relapsed/Refractory Multiple Myeloma: East Asia Subgroup Results of the Randomized, Non-Inferiority, Phase 3 IRAKLIA Study	Abstract #5819 Poster Presentation December 8, 2025 6:00 PM – 8:00 PM
Gaudel	Isatuximab Subcutaneous in Relapsed/Refractory Multiple Myeloma: Exposure-Response and Serum M-Protein Dynamics Analyses from Phase 3 IRAKLIA Study and the Phase 1b Study	Abstract #5826 Poster Presentation December 8, 2025 6:00 PM - 8:00 PM
Lu	Isatuximab Subcutaneous by On-Body Injector in Relapsed/Refractory Multiple Myeloma in the Phase 3 IRAKLIA Study: Effect of Body Weight on Pharmacokinetics and Clinical Outcome	Abstract #5812 Poster Presentation December 8, 2025 6:00 PM - 8:00 PM
Mohan	Low Conversion Rates to Minimal Residual Disease Negativity Despite Improved IMWG Responses with Lenalidomide-Isatuximab Maintenance After Autologous Stem Cell Transplant in Multiple Myeloma	Abstract #5758 Poster Presentation December 8, 2025 6:00 PM - 8:00 PM
Lim	An Immune-Therapeutic Salvage Strategy for 'Functional' High-Risk Multiple Myeloma Incorporating Iberdomide, Isatuximab, and Dexamethasone - the IBIS Study AMaRC 20-01	Abstract #5841 Poster Presentation December 8, 2025 6:00 PM – 8:00 PM
Systemic Mastocytosis
Reiter	Avapritinib Treatment of Patients with Advanced Systemic Mastocytosis: 4-Year Safety, Effect on Bone and First-Line Efficacy Results of the PATHFINDER Clinical Study	Abstract #1022 Oral Presentation December 8, 2025 4:45 PM - 5:00 PM
Tashi	Avapritinib Achieves Deep and Durable Symptom Control with a Well-Tolerated Safety Profile in ISM: Long-Term Outcomes from PIONEER	Abstract #2024 Poster Presentation December 6, 2025 5:30 PM - 7:30 PM
Radia	Effect of Avapritinib on Skin Lesions in Patients with Advanced Systemic Mastocytosis Using a Novel, Artificial Intelligence-Based Technology (PATHFINDER)	Abstract #2030 Poster Presentation December 6, 2025 5:30 PM - 7:30 PM
Castells	Changes in Long-Term Bone Health in Patients Receiving Avapritinib for the Treatment of Indolent Systemic Mastocytosis in the PIONEER Study	Abstract #5582 Poster Presentation December 8, 2025 6:00 PM - 8:00 PM
Luebke	Improved Overall Survival in Patients with Advanced Systemic Mastocytosis Treated with Avapritinib versus Real-World Therapy based on Mutation-Adjusted Risk Score Stratification	Abstract #5595 Poster Presentation December 8, 2025 6:00 PM - 8:00 PM
Panse	An Analysis of Clonal Dynamics in Patients with Indolent Systemic Mastocytosis Treated with Avapritinib in the PIONEER Study	Abstract #5573 Poster Presentation December 8, 2025 6:00 PM - 8:00 PM
George	Diagnostic Evolution in Systemic Mastocytosis: Clinical Impact of WHO 2022 Criteria on Smoldering Systemic Mastocytosis Identification in PIONEER	Abstract #5578 Poster Presentation December 8, 2025 6:00 PM - 8:00 PM
Castells	Interpreting Tryptase Levels and Avoiding Common Pitfalls in Screening for Clonal Mast Cell Disease	Abstract #4774 Poster Presentation December 8, 2025 6:00 PM - 8:00 PM
Transplant
DeFilipp	Response Dynamics to Belumosudil in Chronic Graft-Versus-Host Disease: Characterizing Late Responses and Organ-Specific Response Expectations from the ROCKstar Study	Abstract #6004 Poster Presentation December 8, 2025 6:00 PM – 8:00 PM
Salhotra	The Effect of Belumosudil on the Therapeutic Monitoring of Tacrolimus and Sirolimus in Allogeneic Hematopoietic Transplantation	Abstract #10614 Online-Only
Schultz	Investigating Belumosudil in Children with Refractory Moderate-to-Severe Chronic Graft-Versus-Host Disease: Design of a Phase 1/2 Study	Abstract #10589 Online-Only

 

About WAYRILZ
WAYRILZ (rilzabrutinib) is the first BTK inhibitor for ITP that helps address the root cause of disease through multi-immune modulation. This innovative therapy is approved in the US for adults with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. Additionally, WAYRILZ is approved in the United Arab Emirates for adult patients with persistent or chronic ITP who have had an insufficient response or intolerance to a previous treatment. BTK, expressed in B cells, macrophages, and other innate immune cells, plays a critical role in multiple immune-mediated disease processes and inflammatory pathways. With the application of Sanofi’s TAILORED COVALENCY® technology, WAYRILZ can selectively inhibit the BTK target.

WAYRILZ is being studied across a variety of rare diseases, including wAIHA, IgG4-RD, and SCD. These additional indications are currently under investigation and have not been approved by regulatory authorities.

IMPORTANT SAFETY INFORMATION AND INDICATION FOR U.S. PATIENTS 

What is WAYRILZ (rilzabrutinib)?

WAYRILZ is a prescription medicine that is used to treat adults with persistent or chronic immune thrombocytopenia (ITP) who received a prior treatment that did not work well enough.

It is not known if WAYRILZ is safe and effective in children.

IMPORTANT SAFETY INFORMATION

What should I tell my healthcare provider before taking WAYRILZ?

Tell your healthcare provider about all of your medical conditions, including if you:

• have liver problems
• have kidney problems
• are pregnant or plan to become pregnant. WAYRILZ may harm your unborn baby. If you are able to have a baby, your healthcare provider will do a pregnancy test before starting treatment with WAYRILZ. Females who are able to become pregnant should use an effective birth control during treatment with WAYRILZ and for 1 week after the last dose.
• are breastfeeding or plan to breastfeed. Do not breastfeed during treatment with WAYRILZ and for at least 1 week after the last dose.

Tell your healthcare provider about all the medicines you take, including prescription and overthecounter medicines, vitamins, and herbal supplements. Taking WAYRILZ with certain other medicines may affect how WAYRILZ works and can cause side effects. WAYRILZ may also affect how other medicines work.

What should I avoid while taking WAYRILZ?

You should avoid grapefruit, starfruit and products that have these fruits, and Seville oranges (often used in marmalades) during treatment with WAYRILZ. These products may increase the amount of WAYRILZ in your blood, which increases the risk of side effects of WAYRILZ.

What are the possible side effects of WAYRILZ?

WAYRILZ may cause serious side effects, including:

• Serious infections. WAYRILZ can increase the risk of infections, including serious infections that can lead to death. Your healthcare provider will check you for signs and symptoms of infection during your treatment with WAYRILZ. Tell your healthcare provider right away if you get any signs or symptoms of infection, including fever, chills, or flu-like symptoms.
• Liver problems including Drug-Induced Liver Injury (DILI). Liver problems, which may be severe, life-threatening, or lead to death have happened in people treated with Bruton’s tyrosine kinase (BTK) inhibitors. Your healthcare provider will do blood tests to check your liver before and as necessary during treatment with WAYRILZ. Tell your healthcare provider right away if you have any signs or symptoms of liver problems, including stomach-area (abdominal) pain or discomfort, dark or “tea-colored” urine, or yellowing of the skin or the white part of your eyes.

The most common side effects of WAYRILZ include diarrhea, nausea, headache, stomach area (abdominal) pain, and COVID-19.

These are not all of the possible side effects of WAYRILZ.

Please see enclosed full Prescribing Information, including Patient Information.

About ALTUVIIIO
ALTUVIIIO (recombinant antihemophilic factor, Fc-VWF-XTEN fusion protein) is a first-in-class high-sustained factor VIII therapy that is designed to extend protection from bleeds with once-weekly prophylactic dosing for adults and children with hemophilia A. In adults and adolescents, ALTUVIIIO has a three to four-fold longer half-life relative to standard and extended half-life factor VIII products, providing high-sustained factor activity levels within normal to near-normal range, allowing for once-weekly administration. ALTUVIIIO is the first factor VIII therapy that has been shown to break through the von Willebrand factor ceiling, which imposes a half-life limitation on earlier generation factor VIII therapies. ALTUVIIIO builds on the innovative Fc fusion technology by adding a region of von Willebrand factor and XTEN polypeptides to extend its time in circulation. ALTUVIIIO is currently approved and marketed in the US (granted priority review), Japan, and Taiwan. On June 17, 2024, it was approved by the European Commission for the treatment and prevention of bleeds and perioperative prophylaxis in hemophilia A under the name Altuvoct^®.

ALTUVIIIO is the first factor VIII therapy to receive breakthrough therapy designation in the US and China, US fast track designation, and orphan drug designation in the US and EU.

IMPORTANT SAFETY INFORMATION AND INDICATION FOR U.S. PATIENTS 

INDICATION 
ALTUVIIIO® [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl] is an injectable medicine that is used to control and reduce the number of bleeding episodes in people with hemophilia A (congenital Factor VIII deficiency). 

Your healthcare provider may give you ALTUVIIIO when you have surgery. 

IMPORTANT SAFETY INFORMATION 
What is the most important information I need to know about ALTUVIIIO? 
Do not attempt to give yourself an injection unless you have been taught how by your healthcare provider or hemophilia center. You must carefully follow your healthcare provider's instructions regarding the dose and schedule for injecting ALTUVIIIO so that your treatment will work best for you. 

Who should not use ALTUVIIIO? 
You should not use ALTUVIIIO if you have had an allergic reaction to it in the past. 

What should I tell my healthcare provider before using ALTUVIIIO? 
Tell your healthcare provider if you have had any medical problems, take any medications, including prescription and non-prescription medicines, supplements, or herbal medicines, are breastfeeding, or are pregnant or planning to become pregnant. 

What are the possible side effects of ALTUVIIIO? 
You can have an allergic reaction to ALTUVIIIO. Call your healthcare provider or emergency department right away if you have any of the following symptoms: difficulty breathing, chest tightness, swelling of the face, rash, or hives. 

Your body can also make antibodies called “inhibitors” against ALTUVIIIO. This can stop ALTUVIIIO from working properly. Your healthcare provider may give you blood tests to check for inhibitors. 

The common side effects of ALTUVIIIO are headache and joint pain. 

These are not the only possible side effects of ALTUVIIIO. Tell your healthcare provider about any side effect that bothers you or does not go away. 

Please see full Prescribing Information. 

About the Sanofi and Sobi collaboration
Sobi and Sanofi collaborate on the development and commercialization of Alprolix and Elocta/Eloctate. The companies also collaborate on the development and commercialization of efanesoctocog alfa, or ALTUVIIIO in the US, Japan, and Taiwan, and Altuvoct in Europe. Sobi has final development and commercialization rights in the Sobi territory (essentially Europe, North Africa, Russia, and most Middle Eastern markets). Sanofi has final development and commercialization rights in North America and all other regions in the world excluding the Sobi territory.

About Sobi
Sobi® is a global biopharma company transforming the lives of people with rare and debilitating diseases. Providing reliable access to innovative medicines in the areas of haematology, immunology and specialty care, Sobi has approximately 1,800 employees across Europe, North America, the Middle East, Asia and Australia. In 2024, revenue amounted to SEK 26 billion. Sobi's share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn.

About QFITLIA
QFITLIA (fitusiran) is a first-in-class antithrombin (AT) lowering therapy approved in the US and the United Arab Emirates for prophylactic treatment of adults and pediatric patients (aged 12 and older) living with hemophilia A or B, with or without factor VIII or IX inhibitors, and is administered via subcutaneous injection with a convenient, prefilled pen for the 50 mg dose. QFITLIA prevents bleeds and helps rebalance hemostasis by lowering AT, a protein that inhibits blood clotting, to promote thrombin generation. QFITLIA is a small interference RNA therapeutic that utilizes Alnylam Pharmaceutical Inc.’s ESC-GalNAc conjugate technology.

IMPORTANT SAFETY INFORMATION AND INDICATION FOR U.S. PATIENTS 

INDICATION 
QFITLIA^® (fitusiran) is a prescription medicine used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children 12 years and older with hemophilia A or B with or without Factor VIII or IX inhibitors. 

It is not known if QFITLIA is safe and effective in children younger than 12 years of age. 

IMPORTANT SAFETY INFORMATION 

QFITLIA can cause SERIOUS SIDE EFFECTS, including: 

• Abnormal blood clotting (thrombotic events): Serious blood clots have occurred in people treated with QFITLIA. QFITLIA can cause blood clots to form in the blood vessels in your arms, legs, lungs, heart, brain, eyes, or head. Your risk of blood clots is greater if your antithrombin (AT) blood level is persistently less than 15% or if you have certain other conditions. Your healthcare provider (HCP) will check your AT blood levels before and during treatment with QFITLIA. 
• Gallbladder disease: QFITLIA can cause gallstones and inflammation of your gallbladder, which might require surgery to remove your gallbladder. Tell your HCP right away if you develop stomach pain, indigestion, nausea, or vomiting. Your HCP may temporarily or permanently stop QFITLIA if you develop any of these symptoms. 

What is the most important information I should know about QFITLIA? 
QFITLIA helps your blood form clots. Do not stop using QFITLIA without talking to your HCP. If you miss doses or stop using QFITLIA, you may no longer be protected against bleeding. 

Use of a clotting factor concentrate (CFC) or bypassing agent (BPA) to help protect against bleeding must be stopped within 7 days after your first dose of QFITLIA. 

Your HCP may prescribe on-demand CFC or BPA if you bleed during treatment with QFITLIA.

Carefully follow your HCP’s instructions regarding when to use on-demand treatment with CFC or BPA, including the prescribed dose and timing of the CFC or BPA. 

Get medical help right away if you get any of these signs or symptoms of blood clots during or after treatment with QFITLIA: 

• Swelling, pain, or redness in arms or legs 
• Coughing up blood 
• Shortness of breath 
• Severe chest pain or tightness of the chest 
• Fast heart rate 
• Feeling faint or passing out 
• Severe or persistent headache 
• Difficulty speaking or understanding language 
• Feeling confused 
• Numbness or weakness in your face, arms, or legs 
• Sudden loss or changes in your vision, eye pain, or swelling 

What are the possible side effects of QFITLIA? 

• QFITLIA can cause other serious side effects, including an increase in your blood liver enzymes. Your HCP will do blood tests to check your liver function before and during treatment with QFITLIA. 
• The most common side effects of QFITLIA include viral infection, common cold symptoms, and bacterial infection. 

These are not all the possible side effects of QFITLIA. 

What should I tell my HCP before using QFITLIA? 

• Tell your HCP about all of your medical conditions, including if you have liver problems, a history of gallbladder disease, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. 
• Females who are able to become pregnant: Hormonal birth control may increase your risk of blood clots if used during treatment with QFITLIA. Talk to your HCP about effective forms of non-hormonal birth control you can use before starting and during treatment with QFITLIA. 
• Tell your HCP about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. 

Please see full Prescribing Information, including SERIOUS SIDE EFFECTS, and Medication Guide.

About SARCLISA
SARCLISA (isatuximab) is approved in more than 50 countries, including in the US, EU, Japan, and China, across multiple treatment lines for MM. Based on the ICARIA-MM phase 3 study, SARCLISA is approved in the US, and Japan in combination with Pd for the treatment of patients with R/R MM who have received ≥two prior therapies, including lenalidomide and a proteasome inhibitor. Additionally, SARCLISA is approved in the EU in combination with Pd for the treatment of patients with R/R MM who have received ≥two prior therapies, including lenalidomide and a proteasome inhibitor and have relapsed on the last therapy, and in China for patients who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. Based on the IKEMA phase 3 study, SARCLISA is also approved in more than 50 countries in combination with Kd, including in the US for the treatment of patients with R/R MM who have received one to three prior lines of therapy and in the EU for patients with MM who have received at least one prior therapy. In the US, EU, and China, SARCLISA is approved in combination with VRd as a front-line treatment option in transplant-ineligible NDMM patients, based on the IMROZ phase 3 study. SARCLISA is also approved in the EU in combination with VRd as an induction treatment for transplant-eligible NDMM patients, based on the GMMG-HD7 phase 3 study. In Japan, SARCLISA is approved in combination with VRd as a front-line treatment option regardless of transplant eligibility.

At Sanofi, we are building on a long-standing commitment to oncology as we continue to chase the miracles of science to improve the lives of those living with cancer. We are committed to transforming cancer care by developing innovative, first and best-in-class immunological and targeted therapies for rare and difficult-to-treat cancers with high unmet need.

For more information on SARCLISA clinical studies, please visit www.clinicaltrials.gov.

IMPORTANT SAFETY INFORMATION AND INDICATION FOR US PATIENTS 

What is SARCLISA?

SARCLISA^® is a prescription medicine used in combination with:

• The medicines pomalidomide and dexamethasone, to treat adults who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor to treat multiple myeloma.
• The medicines carfilzomib and dexamethasone, to treat adults with multiple myeloma who have already received 1 to 3 lines of treatment and they did not work or are no longer working.
• The medicines bortezomib, lenalidomide and dexamethasone, to treat adults with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant).

It is not known if SARCLISA is safe and effective in children.

Important Safety Information

Do not receive SARCLISA if you have a severe allergic reaction to isatuximab-irfc or any of the ingredients in SARCLISA (see the list of ingredients in the full Prescribing Information).

Before receiving SARCLISA, tell your healthcare provider about all of your medical conditions, including if you:

• Have an infection.
• Have heart problems, if your healthcare provider prescribes SARCLISA in combination with carfilzomib and dexamethasone for you.
• Have had shingles (herpes zoster).
• Are pregnant or plan to become pregnant. SARCLISA can harm your unborn baby.
  • Females who are able to become pregnant should use an effective method of birth control during treatment and for 5 months after your last dose of SARCLISA. Talk to your healthcare provider about birth control methods that you can use during this time.
  • Tell your healthcare provider right away if you think you are pregnant or become pregnant during treatment with SARCLISA.
  • Before receiving SARCLISA in combination with either pomalidomide or lenalidomide, females and males must agree to the instructions in the pomalidomide or lenalidomide REMS program. The pomalidomide and lenalidomide REMS program have specific requirements about birth control, pregnancy testing, blood donation, and sperm donation that you need to know. Talk to your healthcare provider to learn more about pomalidomide or lenalidomide.
• Are breastfeeding or plan to breastfeed. It is not known if SARCLISA passes into your breast milk. Do not breastfeed during treatment with SARCLISA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive SARCLISA?

• SARCLISA will be given to you by your healthcare provider by intravenous (IV) infusion into your vein.
• SARCLISA in combination with pomalidomide and dexamethasone, or SARCLISA in combination with carfilzomib and dexamethasone is given in treatment cycles of 28 days (4 weeks).
  • Cycle 1 (28-day cycle), SARCLISA is given weekly.
  • Cycle 2 and beyond (28-day cycles), SARCLISA is given every 2 weeks.
     
• SARCLISA in combination with bortezomib, lenalidomide, and dexamethasone is given in treatment cycles of 42 days (6 weeks) from cycle 1 to 4 and in treatment cycles of 28 days (4 weeks) from cycle 5.
  • Cycle 1 (42-day cycle), SARCLISA is given weekly (Days 1, 8, 15, 22, and 29).
  • Cycles 2 to 4 (42-day cycles), SARCLISA is given every 2 weeks (Days 1, 15, and 29).
  • Cycles 5 to 17 (28-day cycles), SARCLISA is given every 2 weeks (Days 1 and 15).
  • Cycles 18 and beyond (28-day cycles), SARCLISA is given every 4 weeks.
     
• Your healthcare provider will decide how many treatments you will receive.
• Your healthcare provider will give you medicines before each infusion of SARCLISA to help reduce the risk of infusion reactions (make them less frequent and severe).
• If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

What are the possible side effects of SARCLISA?

SARCLISA may cause serious side effects, including:

• Infusion reactions. Infusion reactions are common with SARCLISA and can sometimes be severe or life threatening.
  • Your healthcare provider will prescribe medicines before each infusion of SARCLISA to help decrease your risk for infusion reactions or to help make any infusion reaction less severe. You will be monitored for infusion reactions during each infusion of SARCLISA.
  • Your healthcare provider may slow down or stop your infusion, or completely stop treatment with SARCLISA if you have an infusion reaction.
     
  • Get medical help right away if you develop any of the following symptoms of infusion reaction during or after an infusion of SARCLISA:

shortness of breath, wheezing, or trouble breathing swelling of the face, mouth, throat, or tongue

throat tightness palpitations dizziness, lightheadedness, or fainting

headache cough rash or itching nausea runny or stuffy nose chills

• Infections. SARCLISA can cause infections that are severe, life-threatening, or that may lead to death. Your healthcare provider will monitor you for signs and symptoms of infection before and during treatment with SARCLISA. Your healthcare provider may prescribe medicines for you to help prevent infections and treat you as needed if you develop an infection during treatment with SARCLISA. Tell your healthcare provider right away if you develop a fever or any signs or symptoms of infection during treatment with SARCLISA.
  • Decreased white blood cell counts. Decreased white blood cell counts are common with SARCLISA and certain white blood cells can be severely decreased. Fever can occur with low white blood cell counts and may be a sign that you have an infection. Your healthcare provider will check your blood cell counts during treatment with SARCLISA and may prescribe a medicine to help increase your white blood cell counts. Tell your healthcare provider right away if you develop any fever or symptoms of infection during treatment with SARCLISA.
     
• Risk of new cancers. New cancers have happened in people during and after treatment with SARCLISA. Your healthcare provider will monitor you for new cancers during treatment with SARCLISA.
   
• Change in blood tests. SARCLISA may affect the results of blood tests to match your blood type for about 6 months after your last infusion of SARCLISA. Your healthcare provider will do blood tests to match your blood type before you start treatment with SARCLISA. Tell all of your healthcare providers that you are being treated with SARCLISA before receiving blood transfusions.

The most common side effects of SARCLISA in combination with pomalidomide and dexamethasone include:

• upper respiratory tract infection
• lung infection (pneumonia)
• diarrhea
• decreased red blood cell count (anemia)
• decreased platelet count (thrombocytopenia)

The most common side effects of SARCLISA in combination with carfilzomib and dexamethasone include:

upper respiratory tract infection tiredness and weakness high blood pressure diarrhea lung infection (pneumonia) trouble breathing trouble sleeping

bronchitis cough back pain decreased red blood cell count (anemia) decreased platelet count (thrombocytopenia)

 

The most common side effects of SARCLISA in combination with bortezomib, lenalidomide and dexamethasone include:

upper respiratory tract infection diarrhea tiredness and weakness  tingling or numbness of the arms or legs lung infection (pneumonia) muscle or bone pain clouding of your eye (cataract)

constipation swelling of the hands, legs, ankles and feet rash trouble sleeping COVID-19 decreased red blood cell count (anemia) decreased platelet count (thrombocytopenia)

Heart failure can happen during treatment with SARCLISA in combination with carfilzomib and dexamethasone. Tell your healthcare provider right away if you develop any of the following symptoms:

trouble breathing

cough

swelling of your ankles, feet, or legs

 

These are not all the possible side effects of SARCLISA. For more information, ask your healthcare provider or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see accompanying full Prescribing Information, including Patient Information.

About REZUROCK
REZUROCK (belumosudil) is the first and only approved therapy inhibiting Rho-associated coiled-coil kinase 2 (ROCK2). REZUROCK is an immunomodulator that is designed to downregulate inflammation and fibrosis. REZUROCK is approved in the United States for the treatment of adult and pediatric patients 12 years and older with cGVHD after failure of at least two prior lines of systemic therapy.

For more information, visit www.Rezurock.com. 

USE 
REZUROCK^® (belumosudil) is a prescription medicine used to treat adults and children 12 years of age and older with chronic graft-versus-host disease (chronic GVHD) after you have received at least 2 prior treatments (systemic therapy) and they did not work. It is not known if REZUROCK is safe and effective in children less than 12 years old.

IMPORTANT SAFETY INFORMATION

Before taking REZUROCK, tell your healthcare provider about all of your medical conditions, including if you:

• have kidney or liver problems.
• are pregnant or plan to become pregnant. REZUROCK can harm your unborn baby. If you are able to become pregnant, your healthcare provider will do a pregnancy test before starting treatment with REZUROCK. Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment with REZUROCK.
• Females who can become pregnant should use effective birth control during treatment with REZUROCK and for 1 week after the last dose.
• Males with female partners who can become pregnant should use effective birth control during treatment with REZUROCK and for 1 week after the last dose.
• are breastfeeding or plan to breastfeed. It is not known if REZUROCK passes into breast milk. Do not breastfeed during treatment with REZUROCK and for 1 week after the last dose.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. REZUROCK may affect the way other medicines work, and other medicines may affect the way REZUROCK works.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take REZUROCK?

• Take REZUROCK exactly as your healthcare provider tells you to take it.
• Do not change your dose or stop taking REZUROCK without first talking to your healthcare provider.
• Take REZUROCK 1 time a day with a meal.
• Take REZUROCK at about the same time each day.
• Swallow REZUROCK tablets whole with a glass of water.
• Do not cut, crush, or chew REZUROCK tablets.
• Your healthcare provider will do blood tests to check your liver at least 1 time a month during treatment with REZUROCK.
• If you miss a dose of REZUROCK, take it as soon as you remember on the same day. Take your next dose of REZUROCK at your regular time on the next day. Do not take extra doses of REZUROCK to make up for a missed dose.
• If you take too much REZUROCK, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of REZUROCK?

The most common side effects of REZUROCK include:

• Infections
• tiredness or weakness
• nausea
• diarrhea
• shortness of breath
• cough
• swelling
• bleeding
• stomach (abdominal) pain
• muscle or bone pain
• headache
• high blood pressure

Your healthcare provider may change your dose of REZUROCK, temporarily stop, or permanently stop treatment with REZUROCK if you have certain side effects.

REZUROCK may affect fertility in males and females. Talk to your healthcare provider if this is a concern for you.

These are not all the possible side effects of REZUROCK. Call your doctor for medical advice about side effects.

Please see for full Prescribing Information.

About AYVAKIT
AYVAKIT (avapritinib) is the first and only medicine approved by the U.S. Food and Drug Administration (FDA) to treat the root cause of SM. It was FDA approved for the treatment of advanced SM in June 2021 and indolent SM (ISM) in May 2023. It now is indicated in adults with ISM, adults with advanced SM, including aggressive SM (ASM), SM with an associated hematological neoplasm (SM-AHN) and mast cell leukemia (MCL), and adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations. The medicine is approved in the EU as AYVAKYT^® for the treatment of adults with ISM with moderate to severe symptoms inadequately controlled on symptomatic treatment, adults with ASM, SM-AHN or MCL, after at least one systemic therapy, and adults with unresectable or metastatic GIST harboring the PDGFRA D842V mutation. The therapy is not recommended for the treatment of patients with low platelet counts (less than 50,000/µL). Globally, the medicine is approved for one or more indications in more than 30 countries worldwide, including China where it is marketed by CStone Pharmaceuticals, paying tiered percentage royalties on sales.

INDICATION

WHAT IS AYVAKIT^® (avapritinib)?

AYVAKIT^® (avapritinib) is a prescription medicine used to treat adults with:

• A certain type of stomach, bowel, or esophagus cancer called gastrointestinal stromal tumor (GIST) that cannot be treated with surgery or that has spread to other parts of the body (metastatic), and that is caused by certain abnormal platelet-derived growth factor receptor alpha (PDGFRA) genes. Your healthcare provider will perform a test to make sure that you have this abnormal PDGFRA gene and that AYVAKIT is right for you.
• Advanced systemic mastocytosis (AdvSM), including aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL). AYVAKIT is not recommended for the treatment of AdvSM in people with low platelet counts (less than 50 x 10⁹/L).
• Indolent systemic mastocytosis (ISM). AYVAKIT is not recommended in people with low platelet counts (less than 50 X 10⁹/L).

It is not known if AYVAKIT is safe and effective in children.

IMPORTANT SAFETY INFORMATION

AYVAKIT^® (avapritinib) may cause serious side effects, including:

Bleeding in your brain. Serious bleeding in the brain may happen during treatment with AYVAKIT and may lead to death. Stop taking AYVAKIT and tell your healthcare provider right away if you develop any symptoms such as severe headache, nausea, vomiting, vision changes, drowsiness, dizziness, confusion, or severe weakness on one or more side of your body. Bleeding in the brain has not been seen in people treated with AYVAKIT for ISM. If you have AdvSM, your healthcare provider will check your platelet counts before and during treatment with AYVAKIT.

Cognitive effects. Cognitive side effects can happen during treatment with AYVAKIT and can be severe. Tell your healthcare provider if you develop any new or worsening cognitive symptoms including forgetfulness, confusion, getting lost, trouble thinking, drowsiness, trouble staying awake (somnolence), word finding problems, seeing objects or hearing things that are not there (hallucinations), or a change in mood or behavior.

Skin sensitivity to sunlight (photosensitivity). Your skin may be sensitive to the sun or other forms of light (photosensitivity) during treatment with AYVAKIT. Avoid or limit exposure to direct sunlight, sunlamps, and other sources of ultraviolet radiation during treatment and for 1 week after stopping treatment with AYVAKIT. Use sunscreen or wear clothes that cover your skin if you need to be out in the sun.

Before taking AYVAKIT, tell your healthcare provider about all of your medical conditions, including if you:

• history of bulging or weakening of a blood vessel wall (aneurysm) or bleeding in your brain
• have a history of stroke within the last year
• have low platelet counts
• have or have had liver problems
• are pregnant or plan to become pregnant. AYVAKIT can cause harm to your unborn baby
• Females who are able to become pregnant: Your healthcare provider should do a pregnancy test before you start AYVAKIT. You should use effective birth control (contraception) during treatment with AYVAKIT and for 6 weeks after the final dose of AYVAKIT. Talk to your healthcare provider about birth control methods that may be right for you. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with AYVAKIT.
• Males with female partners who are able to become pregnant should use effective birth control (contraception) during treatment and for 6 weeks after the final dose of AYVAKIT.
• are breastfeeding or plan to breastfeed. It is not known if AYVAKIT passes into your breast milk. Do not breastfeed during treatment with AYVAKIT and for at least 2 weeks after the final dose of AYVAKIT. Talk to your healthcare provider about the best way to feed your baby during this time

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. AYVAKIT may affect the way other medicines work, and certain other medicines may affect how AYVAKIT works. Especially tell your healthcare provider if you take estrogen-containing hormonal birth control or medicines that prevent blood clots.

Do not drive or operate hazardous machinery if you have confusion or trouble thinking during treatment with AYVAKIT.

The most common side effects of AYVAKIT in people with GIST include: fluid retention or swelling, nausea, tiredness or weakness, trouble thinking, vomiting, decreased appetite, diarrhea, increased eye tearing, stomach area (abdominal) pain, constipation, rash, dizziness, hair color changes, and changes in certain blood tests.

The most common side effects of AYVAKIT in people with AdvSM include: fluid retention or swelling, diarrhea, nausea, tiredness or weakness, and changes in certain blood tests.

The most common side effects of AYVAKIT in people with ISM include: swelling around your eyes, dizziness, swelling of your arms and legs, and flushing.

Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with AYVAKIT if you develop certain side effects. AYVAKIT may cause fertility problems in females and males. Talk to your healthcare provider if this is a concern for you.

These are not all of the possible side effects of AYVAKIT. Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

AYVAKIT is available in 25-mg, 50-mg, 100-mg and 200-mg tablets.

Please click here to see the full Prescribing Information and Patient Information for AYVAKIT.

About Sanofi
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time.  

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY 

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