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Non-hormonal menopause treatment wins FDA nod

Words by GOLD newsdesk

In a landmark moment for women’s reproductive healthcare, a first-of-its-kind, non-hormonal treatment to reduce menopausal symptoms gained approval on 13 May 2023.

Astellas' fezolinetant or Vezoah is a medicine to be used to treat moderate to severe vasomotor symptoms associated with menopause, such as hot flushes and night sweats. These are reported to occur in around 60% to 80% of women during or after the menopause.

“Today’s approval of fezolinetant is a significant and, I believe, long-awaited milestone for individuals in the US who experience moderate to severe vasomotor symptoms during the menopausal transition,” said Genevieve Neal-Perry, Chair, UNC School of Medicine Department of Obstetrics and Gynecology.

This approval is a welcome step towards meeting the needs of patients who have been reluctant or unable to take other hormone-based treatments. “I am excited that patients will have the option to choose this non-hormonal treatment,” asserts Neal-Perry.

Also commenting on Fezolinetant’s approval, Marci English, Vice President and Head of BioPharma Development, Astellas, said: “FDA approval of this new treatment is a testament to Astellas’ commitment to delivering innovative therapies in areas of unmet need that have been underserved, including women’s health.”

The drug originally was submitted for priority review to FDA in 2022 and was expected to be approved earlier this year, but FDA extended the approval window before making a decision last week.

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