FDA Delays Decision for Astellas’s Menopause Drug Candidate

The FDA has pushed back its decision date by three months on Astellas Pharma’s new drug application (NDA) for fezolinetant, used in treating menopause-related hot flashes and night sweats, from Feb. 22 to May 22, saying it needed more review time.

Fezolinetant is a nonhormonal oral treatment candidate that regulates brain signals to reduce the frequency and severity of moderate-to-severe vasomotor menopause symptoms.

The application includes supporting data from three phase 3 clinical trials. The company had used a priority review voucher to reduce the normal decision time by four months.