FDA delays decision on Bayer menopause drug

The US Food and Drug Administration has delayed its decision on Bayer’s non-hormonal menopause treatment elinzanetant by up to three months.

The agency said it needed more time to complete its review but raised no concerns about the safety or effectiveness of the drug, which is designed to treat moderate to severe hot flushes.

Elinzanetant, to be sold under the brand name Lynkuet, was approved last month in the UK and Canada following three Phase III trials showing good efficacy and long-term safety.

The oral therapy is the first menopause drug to target a neurological pathway. It works by blocking specific brain receptors that regulate body temperature, helping reduce hot flushes and night sweats.

Yesmean Wahdan is senior vice president and head of medical affairs, North America, at Bayer.

Wahdan said: “We are confident in the potential of elinzanetant to provide meaningful clinical benefit to women pending regulatory approval.

“We continue to work with the FDA to make this treatment available for women in menopause with moderate to severe hot flushes.”

The drug was originally developed by UK biotech firm KaNDy Therapeutics, which Bayer acquired in 2020 for US$425m, with up to US$450m in milestone payments due prior to launch.

It acts on KNDy neurons—nerve cells in the brain’s thermoregulatory centre—to alleviate symptoms. While primarily used to treat vasomotor symptoms, it may also support sleep and mood.

Hormone replacement therapy remains an effective option for many, but is unsuitable for some women, including those with a history of cancer, cardiovascular disease or blood clots. This has created demand for non-hormonal treatments.

Wahdan said: “Despite the universal experience of menopause, social stigma and misinformation persist, leaving many women to suffer without treatment and support.

“It’s critical we advance innovation and education in menopause so women can work with their healthcare provider to determine the best option for them.”