A Bayer drug that hits two central nervous system targets to treat moderate-to-severe menopause symptoms has FDA approval, introducing a new non-hormonal therapeutic option that may have an advantage over an Astellas Pharma product that has a two-year head start in this market.
The Bayer drug, elinzanetant, is a small molecule formulated as a soft gel capsule taken once daily before bedtime. Bayer will commercialize this new menopause drug under the brand name Lynkuet.
Hormone therapies are a standard treatment for menopause’s vasomotor symptoms, such as hot flashes and night sweats. But such treatments can raise the risk of cardiovascular complications, so women who have heart issues need non-hormonal options. Lynkuet is a small molecule designed to inhibit two targets, the NK1 and NK3 receptors, both of which play roles in regulating physiological processes such as body temperature. The dual-targeting approach of Lynkuet differentiates it from Astellas’s Veozah, an NK3 receptor-blocking drug that won its FDA approval in 2023.
Lynkuet could also have a safety advantage over the Astellas menopause drug. Last fall, the FDA issued a safety communication about Veozah after a patient who had been taking the once-daily pill for about 40 days developed signs and symptoms of liver injury. Last December, the FDA added a black box warning to the product’s label flagging these risks.
Tadaaki Taniguchi, formerly Astellas’s chief medical officer and now the company’s chief research and development officer, said in a January interview that liver toxicity is a known risk that was identified in clinical testing. He added that this risk is rare and “we believe that the risk/benefit balance is really positive.” For the 2024 fiscal year, Astellas reported 33.8 billion Japanese yen (about $220 million) in Veozah revenue. For the 2025 fiscal year, Astellas projects 50 billion yen (about $330 million) in sales.
Lynkuet was initially developed by KaNDy Therapeutics. When Bayer acquired the women’s health company in 2020, the drug was ready for Phase 3 testing. Lynkuet’s efficacy was evaluated in two placebo-controlled Phase 3 studies. Results showed the drug met the main goals of reducing the frequency and severity of hot flashes measured at weeks 4 and 12.
A third Phase 3 study evaluated the drug for one year with a main goal of assessing safety. Side effects reported in the studies included headache, fatigue, dizziness, and drowsiness. Lynkuet’s label has no black box warning, though the prescribing information directs clinicians to perform bloodwork to test for liver function and injury before a patient starts taking the medication, and then a follow-up test three months afterward.
“Hot flashes, particularly when severe, can have an impact on women’s daily lives and this approval provides healthcare providers with a new treatment option that can be used first line for moderate to severe hot flashes due to menopause,” Dr. JoAnn Pinkerton, professor and director of midlife health at UVA Health and lead investigator in the drug’s OASIS 2 Phase 3 clinical trial, said in a prepared statement.
In the Lynkuet approval announcement Friday, Bayer said it expects the new menopause drug will become available to U.S. patients in November. It is already approved in Australia, Canada, the United Kingdom, and Switzerland. Lynkuet is still under regulatory review in the European Union and other global markets.
Photo: Krisztian Bocsi/Bloomberg, via Getty Images
