FDA approves fezolinetant for vasomotor symptoms caused by menopause

Astellas Pharma’s drug, Veozahtm (fezolinetant), has been approved by the FDA for the treatment of moderate to severe vasomotor symptoms (VMS) caused by menopause. It is the first nonhormonal neurokinin 3 (NK3) receptor antagonist to receive approval for this indication.

“Today’s approval of fezolinetant is a significant and, I believe, long awaited milestone for individuals in the U.S. who experience moderate to severe vasomotor symptoms during the menopausal transition,” said Genevieve Neal-Perry, MD, Ph.D., Chair, UNC School of Medicine Department of Obstetrics and Gynecology in a company press release. “This therapy is based on our understanding of the biology behind hot flashes. I’m excited to know that patients will have the option to choose this nonhormonal treatment.”

Approval is based on the findings of the BRIGHT SKY program. This program included three Phase 3 clinical trials involving over 3,000 participants from the U.S., Canada, and Europe. The results from the pivotal trials, SKYLIGHT 1 and SKYLIGHT 2, demonstrated the effectiveness and safety of fezolinetant in treating moderate to severe VMS. Additionally, the SKYLIGHT 4 safety study provided further information on the long-term safety profile of fezolinetant.