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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.
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Reference News

[1]
With new data, Bayer readies rival to Astellas menopause ...
biopharmadive.com · Mar 19, 2024

Bayer plans to seek regulatory approval for elinzanetant, a drug for menopause symptoms, after positive Phase 3 trial re...

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