Bayer says FDA extends review period for elinzanetant NDA

Bayer (BAYRY) announced that the U.S. FDA has extended the review period for the New Drug Application for elinzanetant. Elinzanetant is the first neurokinin 1 and neurokinin 3 receptor antagonist in late-stage clinical development for the hormone-free treatment of moderate to severe vasomotor symptoms due to menopause. The FDA has determined additional time is needed for a full review of the NDA submission, including information provided to support the application. The extension to the Prescription Drug User Fee Act review period is up to 90 days. The FDA did not raise any concern regarding the general approvability of elinzanetant in its correspondence. “We are confident in the potential of elinzanetant to provide meaningful clinical benefit to women pending regulatory approval,” said Yesmean Wahdan, M.D., Senior Vice President and Head of Medical Affairs, North America, Pharmaceuticals. The NDA is based on the results from the OASIS 1, 2 and 3 Phase III studies evaluating the efficacy and safety of the investigational compound elinzanetant versus placebo. Results from OASIS 1 and 2 were published in August 2024 in The Journal of the American Medical Association. Detailed results of the Phase III study OASIS 3 providing supporting efficacy and additional long-term safety data were presented at The Menopause Society annual meeting in September 2024.