German drugmaker Bayer said this week that its new menopausal relief drug candidate elinzanetant met the main goal in two phase 3 trials of reducing the frequency and severity of vasomotor symptoms – hot flushes – in postmenopausal women, and easing sleep disturbances.
This is welcome news for the group, which is still reeling from November’s setback when it had to abort 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.
Previously, reports Reuters, Bayer had estimated the blood-thinning drug could have peak annual sales of more than $5.5bn, while elinzanetant – which among secondary trial goals was also shown to improve menopause-related quality of life – was given the potential of about $1bn or more per year.
In the race for non-hormonal menopausal symptoms relief drugs, Bayer is behind Japan’s Astellas, which last year won US and European approval for similar treatment Veoza, also known as fezolinetant.
Yet another similar compound, developed by Acer Therapeutics, failed to ease hot flushes in a mid-stage trial last year.
Bayer said the results of a third phase 3 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.
Reuters article – Bayer’s menopausal relief drug succeeds in late-stage trial (Open access)
See more from MedicalBrief archives:
FDA approves pill for menopausal hot flushes
HRT should be given earlier as menopause ‘reshapes the brainʼ – Nature Scientific Reports
New drug cuts number and severity of hot flushes