We last spoke about Astellas Pharma in February, when the company made headlines with its menopause ad that ran during the Superbowl LVII in the US. The ad focused on vasomotor symptoms (VMS), which are hot flashes and night sweats associated with menopause.

Now the company is back with more news regarding its efforts in the menopause space as the FDA has approved VEOZAH (45mg once daily) for the treatment of moderate to sever vasomotor symptoms. According to Astellas VEOZAH is the first nonhormonal neurokinin 3 (NK3) receptor antagonist approved to treat VMS due to menopause.

VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause. VMS are the most common symptoms of menopause for which women seek treatment. In the U.S., about 60% to 80% of women experience these symptoms during or after the menopausal transition. VMS can have a disruptive impact on women’s daily activities and overall quality of life.

“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, M.D., Ph.D., Chair, UNC School of Medicine Department of Obstetrics and Gynecology. “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.”

“VEOZAH uses a novel mechanism of action to target the root cause of VMS due to menopause,” said Marci English, Vice President and Head of BioPharma Development, Astellas. “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 approval is supported by results from the BRIGHT SKY program, which included three Phase 3 clinical trials as part of a development program that collectively enrolled over 3,000 individuals across the U.S., 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 due to menopause. Data from the SKYLIGHT 4 safety study further characterizes the long-term safety profile of fezolinetant.

Marketing authorization applications for fezolinetant are also under regulatory review in the EU, Switzerland and Australia.

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