May 17, 2024
Bayer Menopause Drug Shows Positive Result in Late-Stage Trials
, Bloomberg News
(Bloomberg) -- Bayer AG said a positive outcome from twin late-stage trials on a promising experimental menopause treatment will help it seek regulatory approval.
The German company published more data on the drug, elinzanetant, which lowers the frequency and severity of hot flashes, and said it met all the research goals in two studies that included about 800 post-menopausal women. The results expanded on positive top-line data that Bayer published in January and confirmed that the therapy, administered orally once a day, outperformed a placebo over a 12-week window.
The medicine also hit other goals in the trials, including reducing hot flashes within the first week of treatment, limiting sleep disturbances and improving menopause-related quality of life, Bayer said.
Shares of Bayer rose more than 1% in early trading. The company’s stock is down more than 40% in the past year, weighed down by litigation issues in its crop science unit.
In March, Bayer published more positive data from a third late-stage trial that evaluated the medicine over a full year. The company plans to include data from all three studies in its application to regulators.
With elinzanetant, Bayer is developing an alternative to hormones for some of the billions of women experiencing menopause symptoms that can affect sleep, mood and quality of life, forcing some out of the workforce. Elinzanetant works on two different targets in the brain, seeking to modulate a group of neurons that can become hyperactive with the decrease of estrogen levels, Bayer said.
Last year, the US Food and Drug Administration approved a similar therapy from Astellas Pharma Inc. called Veozah, which binds to and blocks the activities of the so-called neurokinin 3 receptor in the brain. Bayer’s drug targets that receptor as well as another one called neurokinin 1.
“Many women experience discomfort for months or even years, with the majority of symptoms left untreated,” JoAnn Pinkerton, director of midlife health center at UVA Health, said in the statement.
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