A Bayer drug that hits two central nervous system targets to deal with moderate-to-severe menopause signs has FDA approval, introducing a brand new non-hormonal therapeutic choice that will have a bonus over an Astellas Pharma product that has a two-year head begin on this market.
The Bayer drug, elinzanetant, is a small molecule formulated as a gentle gel capsule taken as soon as every day earlier than bedtime. Bayer will commercialize this new menopause drug underneath the model title Lynkuet.
Hormone therapies are a typical therapy for menopause’s vasomotor signs, resembling scorching flashes and night time sweats. However such therapies can increase the chance of cardiovascular problems, so ladies who’ve coronary heart points want non-hormonal choices. Lynkuet is a small molecule designed to inhibit two targets, the NK1 and NK3 receptors, each of which play roles in regulating physiological processes resembling physique temperature. The twin-targeting strategy of Lynkuet differentiates it from Astellas’s Veozah, an NK3 receptor-blocking drug that won its FDA approval in 2023.
Lynkuet might even have a security benefit over the Astellas menopause drug. Final fall, the FDA issued a security communication about Veozah after a affected person who had been taking the once-daily capsule for about 40 days developed indicators and signs of liver damage. Final December, the FDA added a black box warning to the product’s label flagging these dangers.
In January interview, Astellas Chief Medical Officer Tadaaki Taniguchi mentioned liver toxicity is a identified danger that was recognized in scientific testing. He added that this danger is uncommon and “we consider that the chance/profit stability is basically optimistic.” For the 2024 fiscal yr, Astellas reported 33.8 billion Japanese yen (about $220 million) in gross sales. For the 2025 fiscal yr, Astellas tasks 50 billion yen (about $330 million) in gross sales.
Lynkuet was initially developed by KaNDy Therapeutics. When Bayer acquired the ladies’s well being firm in 2020, the drug was prepared for Part 3 testing. Lynkuet’s efficacy was evaluated in two placebo-controlled Part 3 research. Outcomes confirmed the drug met the principle targets of lowering the frequency and severity of scorching flashes measured at weeks 4 and 12.
A 3rd Part 3 examine evaluated the drug for one yr with a primary aim of assessing security. Negative effects reported within the research included headache, fatigue, dizziness, and drowsiness. Lynkuet’s label has no black field warning, although the prescribing data directs clinicians to carry out bloodwork to check for liver operate and damage earlier than a affected person begins taking the remedy, after which a follow-up take a look at three month afterward.
“Sizzling flashes, significantly when extreme, can have an effect on ladies’s every day lives and this approval gives healthcare suppliers with a brand new therapy choice that can be utilized first line for reasonable to extreme scorching flashes because of menopause,” Dr. JoAnn Pinkerton, professor and director of midlife well being at UVA Well being and lead investigator within the drug’s OASIS 2 Part 3 scientific trial, mentioned in a ready assertion.
Within the Lynkuet approval announcement Friday, Bayer mentioned it expects the brand new menopause drug will develop into out there to U.S. sufferers in November. It’s already accepted in Australia, Canada, the UK, and Switzerland. Lynkuet continues to be underneath regulatory assessment within the European Union and different world markets.
Photograph: Krisztian Bocsi/Bloomberg, by way of Getty Photos
