Astellas' Menopause Drug Under FDA Review

  • The FDA accepted Astellas Pharma Inc's ALPMF menopause treatment for approval five months after the therapy hit a speed bump in a phase 3 trial conducted in Asia.
  • With the FDA's acceptance of Astellas' marketing application for fezolinetant, the company expects a regulatory decision by February 22, 2023, following the use of a priority review voucher.
  • The application is based on the results from the BRIGHT SKY program, which included three Phase 3 clinical trials that collectively enrolled over 2,800 women with vasomotor symptoms across the U.S. and Europe. 
  • Related Content: Astellas' Menopause Drug Suffers Setback After Failed Asian Trial.
  • Fezolinetant beat placebo in reducing the frequency and severity of moderate to severe vasomotor symptoms, which include hot flashes and night sweats.
  • Astellas proposes a 45 mg daily dose within the application, subject to the FDA's review.
  • For the priority review voucher, Astellas booked 13.1 billion yen ($97 million) worth of amortization for the intangible asset in the first quarter of the fiscal year 2022.
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