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.