Menopause relief drug: USFDA extends review period for Bayer Elinzanetant
Berlin: Bayer has announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for elinzanetant, the first neurokinin 1 and neurokinin 3 receptor antagonist for the treatment of moderate to severe vasomotor symptoms (VMS; also known as hot flashes) 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 PDUFA review period is up to 90 days. The FDA did not raise any concern regarding the general approvability of elinzanetant in its correspondence.
“With the consistent positive results from our clinical Phase III program assessing the efficacy and safety of elinzanetant, we remain confident about elinzanetant’s potential as a new treatment option for moderate to severe vasomotor symptoms associated with menopause”, said Dr. Christian Rommel, member of the Executive Committee of Bayer’s Pharmaceuticals Division and Global Head of Research and Development. “As we continue to work with the FDA during the ongoing review, we are fully committed to making elinzanetant available to women in the U.S. as soon as we receive FDA approval.”
The NDA is based on the positive results from the Phase III studies OASIS 1, 2 and 3 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 (JAMA). Detailed results of the Phase III study OASIS 3 providing supporting efficacy and additional long-term safety data were presented at The Menopause Society (TMS) annual meeting in September 2024.
In the last 30 days, elinzanetant was approved under the brand name Lynkuet in the United Kingdom and Canada. Submissions for marketing authorizations for elinzanetant are also ongoing in the European Union and other markets around the world.
