FDA pushes back review date for Astellas menopause drug

Feb. 20, 2023

Astellas Pharma announced this week that the FDA has pushed back its original priority review Prescription Drug User Fee Act (PDUFA) goal date for its menopause drug, fezolinetant, to May 22, 2023.

The Tokyo-based drugmaker had its NDA accepted for the investigational new drug back in August of 2022. The NDA’s acceptance hinged on three phase 3 trials which enrolled 2,800 women from across the U.S., Canada and Europe. Fezolinetant targets moderate to severe vasomotor symptoms (VMS), such as hot flashes or night sweats, and works by targeting a selective neurokinin 3 (NK3) receptor antagonist. 

Drugs like fezolinetant have been found to suppress luteinizing hormone secretion, therefore decreasing estradiol and progesterone levels in women and testosterone levels in men. Astellas first got its hands on the investigational drug in 2017, when it completed the acquisition of Ogeda SA for $500 million upfront.