- The FDA accepted Astellas Pharma Inc’s (OTC: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.
Reuters Reported Sunday India’s Tata Group to Open 100 Exclusive Apple Stores
https://www.reuters.com/technology/indias-tata-group-open-100-exclusive-apple-stores-report-2022-12-12/#:~:text=Dec%2012%20(Reuters)%20%2D%20Indian,people%20aware%20of%20the%20matter.
