Astellas New Menopause Drug Fails to Gain FDA Approval.

Astellas’ effort to launch menopause drug candidate fezolinetant hit a snag at the last minute. Just days before the date of the approval decision, the FDA extended the review by three months to allow more time to complete the review.
Last year, Japan’s Astellas used a “priority review voucher” to beat the four-month review time for its application for approval, leading up to the FDA’s Feb. 22 decision date. The use of the coupon reflected Astellas’ confidence in the drug candidate, which it has identified (PDF) as one of a handful of assets that will add $8.9 billion in combined sales by 2025, followed by rival Bayer Therapeutics.

Now the FDA has thwarted Astellas’ goal of accelerated approval by failing to complete its review by the deadline. With the review complete, the FDA pushed back the decision date to May 22. Astellas hit back.

“We remain confident in the clinical profile of fezolinetant and the potential benefits it may bring to women with moderate to severe [vasomotor symptoms] due to menopause, and we continue to work with the FDA to review the fezolinetant NDA,” said Ahsan Arozullah, MD, Astellas vice president and director of therapeutic area development, in the release.

Delay is one of the minor setbacks Fezolinetant suffers from. After showing a neurokinin-3 receptor antagonist could reduce hot flashes in two global Phase 3 trials, Astellas blinded a trial of 302 women in China, Korea, and Taiwan about a year ago.
The Institute for Clinical and Economic Review (ICER) assessed that the evidence that fezolinetant was better than no medication was “promising but unclear.” ICER found that there was insufficient evidence for the effectiveness of fesolinetant compared with postmenopausal hormone therapy, an established treatment for hot flashes that is contraindicated in some women.
Any delay for Astellas, which bought fezolinetant for 500 million euros ($534million) in 2017, is a potential boost for Bayer. In 2020, the German conglomerate entered the fray, paying $425 million for KaNDy Therapeutics and launching three late-stage clinical trials the following year. The preferred end dates for the three Bayer studies are between March and July of this year.

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