Astellas Pharma’s Pill for Menopause Hot Flashes Approved by the US FDA

Astellas Pharma Inc announced that the US Food and Drug Administration (FDA) has given approval for the oral drug VEOZAHTM (fezolinetant) 45 mg to treat moderate to severe vasomotor symptoms (VMS) caused by menopause.

This is the first nonhormonal neurokinin 3 (NK3) receptor antagonist approved for this purpose. VMS symptoms can include hot flashes and night sweats. These common symptoms of menopause can significantly impact women’s daily activities and overall quality of life.

Genevieve Neal-Perry, M.D., Ph.D., Chair, UNC School of Medicine Department of Obstetrics and Gynecology said:

“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. 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.”

Before menopause, there is a balance between estrogens (hormones made by a woman’s ovaries) and neurokinin B (NKB), a brain chemical. This balance regulates the body’s temperature control center located in a specific area of the brain. As the body goes through menopause, estrogens decline and this balance is disrupted. This imbalance can lead to very uncomfortable symptoms called VMS. VEOZAH helps to restore the balance by blocking NKB in the temperature control center to reduce the number and intensity of hot flashes.

Marci English, Vice President and Head of BioPharma Development, 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.”

The endorsement of VEOZAH is backed by findings from the BRIGHT SKY™ initiative, which encompasses three Phase 3 clinical trials conducted as part of a development scheme that recruited more than 3,000 participants from the United States, Canada, and Europe. The outcomes of the SKYLIGHT 1™ and SKYLIGHT 2™ pivotal trials describe the effectiveness and safety of fezolinetant in treating moderate to severe VMS due to menopause. The SKYLIGHT 4™ safety study’s findings provide additional insight into the long-term safety profile of fezolinetant.

Applications seeking marketing authorization for fezolinetant are currently undergoing regulatory review in the European Union, Switzerland, and Australia.

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