FDA accepts Astellas menopause drug NDA

Aug. 18, 2022

Tokyo-based Astellas Pharma announced this week that the U.S. FDA has accepted its New Drug Application for fezolinetant, an investigational new drug for the treatment of menopause-associated symptoms such as hot flashes or night sweats. 

The indicated PDUFA date is February 22, 2023, as Astellas is also employing a priority review voucher. The NDA acceptance hinged on three phase 3 trials which enrolled 2,800 women from across the U.S., Canada and Europe. The trials evaluated the efficacy and safety of the drug for the treatment of moderate to severe vasomotor symptoms (VMS) caused by menopause or sex-related hormone disorders. 

Astellas’ senior vice president and head of Development Therapeutic Areas Ahsan Arozullah said that “We look forward to the FDA’s review of our application, and the potential to offer a first-in-class non-hormonal treatment option to reduce the frequency and severity of moderate to severe VMS associated with menopause.”

Fezolinetant 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. Fezolinetant is also a GnRH modulator, meaning that it can target the secretion of hormones that affect gonads, influencing fertility as well as the production of sex steroids. The proposed dosage is 45mg daily, which could be subject to change once the FDA reviews the rest of the trial data.