Bayer Prepares Menopause Drug Rival to Astellas’ Veozah for Regulatory Filings Following Successful Phase 3 Trials

1. Bayer achieved success in all three Phase 3 trials for its menopause drug candidate, elinzanetant, setting the stage for regulatory approval filings.
2. Elinzanetant is a dual neurokinin-1,3 (NK-1,3) receptor antagonist designed to treat hot flashes associated with menopause.
3. The final Phase 3 trial demonstrated improvements in the frequency of moderate to severe hot flashes and had a consistent safety profile over 52 weeks of daily oral dosing.
4. Bayer plans to submit data from all three trials in applications for approval, potentially competing with Astellas' NK3 receptor antagonist Veozah, which received FDA approval in May 2023.
5. Unlike Veozah, elinzanetant targets both NK1 and NK3 receptors, which might offer advantages like improving sleep, although specific data on sleep disturbances has not been released.
6. Bayer views elinzanetant as a potential blockbuster amidst the company's strategic shift away from women's health.
7. Astellas has faced commercial challenges with Veozah due to lower-than-expected demand and issues with insurer reimbursement.