FDA accepts new drug application for fezolinetant

The FDA accepted a new drug application from Astellas for fezolinetant, a nonhormonal drug for treating moderate to severe menopause-related vasomotor symptoms, according to a company press release.

Astellas submitted the NDA based on safety and efficacy data from three phase 3 trials.

“The FDA’s acceptance of our NDA for fezolinetant brings us one step closer to advancing care for women in the U.S. who experience [vasomotor symptoms],” Ahsan Arozullah, MD, MPH, senior vice president and head of development therapeutic areas at Astellas, said in the release. “We look forward to the FDA’s review of our application, and the potential to offer a first-in-class nonhormonal treatment option to reduce the frequency and severity of moderate to severe [vasomotor symptoms] associated with menopause.”

The Prescription Drug User Fee Act target action date, which will follow a priority review voucher, is Feb. 22, 2023.