FDA to Review NDA for Nonhormonal Therapy for Menopause

If approved, fezolinetant would treat patients with moderate-to-severe hot flashes and/or night sweats associated with menopause. The PDUFA date is Feb 22, 2023.

The FDA has accepted Astellas Pharma’s new drug application (NDA) for fezolinetant. Astellas seeking approval to treat moderate-to-severe vasomotor symptoms (VMS) associated with menopause, which is characterized by hot flashes and/or night sweats. The PDUFA target action date is Feb. 22, 2023, following use of a priority review voucher. Astellas proposes a 45 mg daily dose.

“The FDA's acceptance of our NDA for fezolinetant brings us one step closer to advancing care for women in the United States who experience VMS," Ahsan Arozullah, M.D., senior vice president and head of development therapeutic areas at Astellas, said in a press release.

Fezolinetant is an oral, nonhormonal therapy that works by blocking neurokinin B (NKB) binding on the KNDy neuron to moderate neuronal activity in the hypothalamus to reduce the frequency and severity of symptoms associated with menopause.

The NDA was submitted in June 2022. The application is supported by results from the BRIGHT SKY program, which included three phase 3 clinical trials that collectively enrolled more than 2,800 women with VMS across the United States, Canada and Europe. Results from the SKYLIGHT 1 and SKYLIGHT 2 pivotal trials characterize the efficacy and safety of fezolinetant for the treatment of moderate to severe VMS associated with menopause. Data from the SKYLIGHT 4 safety study further characterizes the long-term safety profile of fezolinetant.

Results of the phase 3 SKYLIGHT 1, released in May 2022, found that fezolinetant met the co-primary endpoints of reduction in daily (24 hours) mean frequency and severity of moderate-to-severe VMS versus placebo weeks four and 12. Headache was the most common adverse event in the fezolinetant groups