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Bayer Prepares to Seek Approval for Menopause Drug Elinzanetant Following Positive Phase 3 Trial Results

Bayer plans to seek regulatory approval for elinzanetant, a drug aimed at alleviating menopause symptoms, after positive results from a third Phase 3 trial. The drug has shown efficacy in reducing hot flashes and improving sleep in menopausal women, positioning it as a competitor to Astellas Pharma's Veozah.

Bayer has announced its intention to seek regulatory approval for elinzanetant, a drug designed to treat symptoms of menopause, following encouraging results from a third Phase 3 trial. This development comes after the drug demonstrated success in two previous late-stage studies, where it effectively reduced the frequency of hot flashes and improved sleep quality in women experiencing moderate-to-severe menopausal symptoms. The latest trial not only reaffirmed the drug's efficacy but also provided longer-term safety data.

Elinzanetant, if approved, will enter the market as a direct competitor to Astellas Pharma's Veozah, a similar medication aimed at addressing menopausal symptoms. Bayer's commitment to women's health research, despite a strategic shift towards areas like rare diseases and immunology, underscores the potential it sees in elinzanetant. The drug, acquired through the purchase of KaNDy Therapeutics in 2020, has been a significant part of Bayer's portfolio and is considered a potential blockbuster by the company's pharmaceutical division head, Stefan Oelrich. He believes elinzanetant could revolutionize the treatment of menopausal symptoms, highlighting its importance in Bayer's future plans.


Reference News

With new data, Bayer readies rival to Astellas menopause ...

Bayer plans to seek regulatory approval for elinzanetant, a drug for menopause symptoms, after positive Phase 3 trial results. It aims to compete with Astellas Pharma's Veozah. Despite shifting focus from women's health, Bayer sees elinzanetant as a potential blockbuster in treating menopausal symptoms.

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