BERLIN: Bayer, a leading pharmaceutical company based in Germany, has announced its intention to seek regulatory approval for its menopause drug following positive results from a third late-stage trial. The daily pill has demonstrated efficacy in easing hot flashes, offering hope for women experiencing symptoms associated with menopause.
In a statement released by Bayer, the company revealed that the Phase III trial of its elinzanetant drug candidate has provided compelling data on both efficacy and long-term safety. This trial, along with data from two earlier studies, supports Bayer’s decision to file requests for approval for the treatment of moderate to severe vasomotor symptoms, commonly known as hot flashes, related to menopause.
The promising results from the elinzanetant trials mark a significant development for Bayer’s pharmaceutical division, which recently faced setbacks following the discontinuation of a major late-stage trial for a new anti-blood-clotting therapy in November. Despite this setback, Bayer remains hopeful about the potential of its menopause drug, which was estimated to have annual sales potential of over a billion dollars.
The success of Bayer’s menopause drug comes amidst competition in the market for non-hormonal relief of menopausal symptoms. While Bayer is trailing behind Japan’s Astellas, which secured US and European approval for a similar treatment called Veoza (fezolinetant) last year, the positive trial results position Bayer as a strong contender in this space.
However, not all drug candidates in this category have fared well. Acer Therapeutics’ similar compound failed to demonstrate efficacy in easing hot flashes in a mid-stage trial conducted last year, underscoring the challenges in developing effective treatments for menopausal symptoms.
