FDA Extends Review of Bayer Menopause Drug Elinzanetant by 3 Months

The U.S. Food and Drug Administration has extended by up to 90 days its review of Bayer’s new drug application for elinzanetant, a non-hormonal therapy intended to ease moderate-to-severe hot flashes linked to menopause. Bayer said the agency did not raise concerns about the drug’s overall approvability but needs additional time to complete its assessment. Elinzanetant, to be marketed as Lynkuet, has already secured regulatory clearance in the U.K. and Canada and is based on data from three Phase III OASIS studies that showed significant reductions in the frequency and severity of vasomotor symptoms without signs of liver toxicity. Bayer submitted the application in August 2024 and has projected potential peak annual sales of at least $1 billion. If authorized, elinzanetant would compete with Astellas Pharma’s Veozah, the first FDA-approved non-hormonal drug in this class, which has faced a slow commercial launch and now carries a liver-injury warning. Bayer said it remains confident in elinzanetant’s market prospects and is working with the FDA to secure approval as quickly as possible.