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HomeNews UpdateBayer seeks approval for ‘hot flushes’ drug

Bayer seeks approval for ‘hot flushes’ drug

German pharmaceutical company Bayer will request regulatory approval for its menopause medication after the daily pill was shown to ease hot flushes in a third late-stage trial, a relief for the drugmaker after a recent development setback.

Bayer said its phase 3 trial with its elinzanetant drug candidate provided supporting data on efficacy and long-term safety, so along with data from two earlier studies, it would file requests for approval for the treatment of moderate to severe vasomotor symptoms – hot flushes – associated with menopause.

Reuters reports that the readouts mark a slight turn of fortune for Bayer, which in November aborted a large late-stage trial because a new anti-blood-clotting therapy did not work as anticipated, derailing its most promising drug development project.


Reuters article – Bayer to seek approval for menopausal relief drug after third trial win


See more from MedicalBrief archives:


Menopausal relief drug meets late-stage trial goal


Hormone therapies best for menopause symptoms, new review finds


HRT should be given earlier as menopause ‘reshapes the brainʼ – Nature Scientific Reports



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