Reporting by Ludwig Burger in Frankfurt . Editing by Matthew Lewis
Jan 9, 2024
Bayer said its menopausal relief drug eased hot flashes and improved sleep
FRANKFURT, Jan 8 (Reuters) - Bayer said its menopausal relief drug eased hot flashes and improved sleep in two late-stage trials, much-needed good news for the German group's pharmaceuticals unit that is reeling from a recent development setback.
Germany's Bayer (BAYGn.DE), opens new tab said in a statement on Monday that its elinzanetant drug candidate met the main goal in two Phase III trials of reducing the frequency and severity of vasomotor symptoms, also known as hot flashes, in postmenopausal women.
The read-out marks a slight turn of fortune for embattled Bayer, which in November aborted a large late-stage trial testing a new anti-blood-clotting drug due to lack of efficacy, throwing its most promising development project into doubt.
Prior to the setback, Bayer had estimated the blood-thinning drug could have peak annual sales of more than 5 billion euros ($5.5 billion), while elinzanetant was given the potential of about a billion dollars or more per year. Among secondary trial goals, the drug was also shown to ease sleep disturbances and improve menopause-related quality of life. Further details of the trials would be presented at as yet undisclosed medical conferences, it added.
In the race for non-hormonal menopausal symptoms relief drugs, Bayer is behind Japan’s Astellas (4503.T), opens new tab, 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.
Bayer added that the results of a third Phase III study testing its elinzanetant are expected in the coming months and that it plans to submit data from all three trials to seek approval from health authorities thereafter.
Reporting by Ludwig Burger in Frankfurt Editing by Matthew Lewis