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Press release
Astellas Submits Fezolinetant New Drug Application to U.S. FDA
Jun 24, 2022
Application targets treatment of moderate to severe vasomotor symptoms associated (VMS) with menopause

TOKYO, June 24, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced a New Drug Application (NDA) for fezolinetant has been submitted to the U.S. Food and Drug Administration (FDA). Fezolinetant is an investigational oral, nonhormonal compound seeking approval for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.1,2

“In the United States, 60% to 80% of individuals experience VMS during or after the menopausal transition, with limited nonhormonal treatment options,” said Ahsan Arozullah, M.D., M.P.H., Senior Vice President and Head of Development Therapeutic Areas, Astellas. “The fezolinetant NDA submission to the U.S. FDA is an important step in our efforts to bring to patients a first-in-class, nonhormonal treatment option to reduce the frequency and severity of moderate to severe VMS associated with menopause.”

The NDA submission is based on results from two pivotal Phase 3 clinical trials, SKYLIGHT 1™ and SKYLIGHT 2™, and the Phase 3 long-term safety study, SKYLIGHT 4™.

Fezolinetant is an investigational selective neurokinin 3 (NK3) receptor antagonist. The safety and efficacy of fezolinetant are under investigation and have not been established.

Astellas is reviewing the financial impacts of this submission for the fiscal year ending March 31, 2023.

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