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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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