Bayer revealed that the U.S. FDA has extended the review period for the company’s once-daily, non-hormonal treatment for moderate to severe vasomotor symptoms (hot flashes) associated with menopause.
The company’s oral neurokinin 1 and neurokinin 3 receptor antagonist, elinzanetant, was originally given a PDUFA date of July 26, 2025. The extension to the PDUFA review period will be up to 90 days.
According to Bayer, the agency did not raise any concern regarding the general approvability of elinzanetant in its correspondence, but told the company that additional time was needed for a full review of the NDA submission, including information provided to support the application.
Elinzanetant was approved earlier this month by the UK’s MHRA, under the brand name Lynkuet.
Elinzanetant is thought to address vasomotor symptoms by modulating a group of estrogen sensitive neurons, called KNDy neurons, in the hypothalamus region of the brain. Bayer shared three positive phase 3 trial readouts for the drug in 2024, in which elinzanetant demonstrated statistically significant reductions in the frequency and severity of moderate to severe vasomotor symptoms from baseline to weeks 4 and 12 compared to the placebo.