FDA Approves Astellas’ Non-hormonal Menopause Treatment After Extended Review

by Reed Slater
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Following a lengthy and delayed review process, the FDA notified Astellas that the agency had approved its menopause and vasomotor symptoms (VMS) treatment, Veozah (Fezolinetant), on May 12. The nonhormonal therapy could prove fruitful for the many women who cannot take hormonal menopause treatments.

Related Article: Astellas Clears Primary Endpoints In Prostate Cancer And Menopause Trials

A New Alternative for Women Experiencing VMS

VMS is a collection of symptoms that women going through menopause may experience, including hot flashes and night sweats. About 60% to 80% of women experience these symptoms during or after menopause. VMS is the most common cause for seeking treatment in women going through menopause and can significantly impact daily activities and quality of life. 

Most VMS treatments include some kind of hormone component to relieve symptoms, but Astellas developed Veozah as a nonhormonal treatment to appeal to those who may not be able to take hormone-based therapies. 

Astellas designed Veozah (Fezolinetant) as a neurokinin 3 (NK3) receptor antagonist, which blocks certain neurons in the thermoregulatory part of the brain responsible for hot flashes and night sweats. Veozah’s most recent approval marks the first-ever NK3 receptor antagonist approval to treat moderate to severe hot flashes from menopause. 

The FDA based the approval on results from the BRIGHT SKY program, which involved several clinical trials, including SKYLIGHT 1, 2, and 4 clinical trials. These trials enrolled over 3,000 participants across the U.S., Canada, and Europe and demonstrated Veozah’s safety and efficacy in women with VMS. 

Marci English, Vice President and Head of BioPharma Development at Astellas, said, “VEOZAH uses a novel mechanism of action to target the root cause of VMS due to menopause. FDA approval of this new treatment for moderate to severe VMS due to menopause is a testament to Astellas’ commitment to delivering innovative therapies in areas of unmet need that have been underserved, including women’s health.”

A Long Road to Approval

Veozah’s journey to FDA approval took a handful of twists and turns, but after it all, the FDA still gave the nod to the drug for its value in treating VMS caused by menopause.

Astellas used a priority review voucher (PRV) when it first submitted Veozah’s New Drug Application (NDA) in August last year. The regulatory agency accepted the application and the voucher before setting a Prescription Drug User Fee Act (PDUFA) goal date of February 22, 2023. 

All seemed to be going to plan until the FDA notified Astellas on February 17, just five days before it was set to render a decision, that it needed extra time to review Veozah. The FDA set a new PDUFA goal date of May 22.

A little more than a week ahead of the extended schedule, the FDA got back to Astellas with the good news that Veozah passed its review board and received approval. Now, Astellas says Veozah is under regulatory review in the EU, Switzerland, and Australia. 

Veozah’s FDA approval marks a milestone in menopause and VMS treatment. The nonhormonal  NK3 receptor antagonist therapy provides many more women with the opportunity to relieve hot flashes and night sweats as a result of menopause.

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