FDA Extends Review of Fezolinetant for Menopause Symptoms

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The review has been extended by three months. The new Prescription Drug User Fee Act (PDUFA) date is May 22, 2023.

The FDA has extended the Prescription Drug User Fee Act (PDUFA) goal date for Astellas’ fezolinetant, which is being reviewed to treat patients with moderate-to-severe vasomotor symptoms (VMS) due to menopause. The PDUFA goal date has been extended three months to May 22, 2023.

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.

Ahsan Arozullah, M.D.

Ahsan Arozullah, M.D.

“We remain confident in the clinical profile of fezolinetant and the potential benefits it could bring to women experiencing moderate to severe VMS due to menopause, and we will continue to work with the FDA on its review of the NDA for fezolinetant,” Ahsan Arozullah, M.D., M.P.H., senior vice president and head of development therapeutic areas at Astellas, said in a press release.

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 to treat patients with vasomotor symptoms associated with menopause. Data from the SKYLIGHT 4 safety study further characterizes the long-term safety profile of fezolinetant.

Related: FDA to Review NDA for Nonhormonal Therapy for Menopause

Findings from the SKYLIGHT 1 trial showed fezolinetant met all four co-primary endpoints, demonstrating a statistically significant reduction from baseline in the frequency and severity of moderate-to-severe vasomotor symptoms at weeks 4 and 12 versus placebo.

Headache was the most common treatment emergent adverse event in the fezolinetant groups and was reported by 5.2%, 6.4% and 7.4% in the 30 mg, 45 mg and placebo groups, respectively. Serious treatment emergent adverse event occurred in less than 2% of patients in the fezolinetant groups.

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