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

By Thomson Reuters Mar 19, 2024 | 2:36 AM

By Ludwig Burger

FRANKFURT (Reuters) -Bayer said on Tuesday that it would request regulatory approval for its menopause drug after the daily pill was shown to ease hot flashes in a third late-stage trial, providing some relief for its pharmaceuticals unit that is reeling from a recent development setback.

Germany’s Bayer said in a statement that a third Phase III trial with its elinzanetant drug candidate provided supporting data on efficacy and long-term safety.

Together with data from two earlier studies, Bayer would file requests for approval for the treatment of moderate to severe vasomotor symptoms, also known as hot flashes, associated with menopause.

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

Bayer had previously estimated the blood-thinning drug could have peak annual sales of more than 5 billion euros ($5.5 billion), while menopause drug elinzanetant was given the potential of about a billion dollars or more per year.

In the race for non-hormonal menopausal symptoms relief drugs, Bayer is behind Japan’s Astellas, which last year won U.S. and European approval for similar treatment Veoza, also known as fezolinetant.

Yet another similar compound, developed by Acer Therapeutics, failed to ease hot flashes in a mid-stage trial last year.

($1 = 0.9106 euros)

(Reporting by Ludwig BurgerEditing by Miranda Murray)