Bayer's menopause drug gets FDA approval, bringing competition to Astellas products
A Bayer drug that targets two central nervous system targets to treat moderate to severe menopausal symptoms has won FDA approval, introducing a new non-hormonal treatment option that may have an advantage over Astellas Pharmaceuticals, which has a two-year lead in the market.
Bayer's drug elinzanetant is a small molecule softgel that is taken once daily at bedtime. Bayer will commercialize the new menopause drug under the brand name Lynkuet.
Hormone therapy is the standard treatment for the vasomotor symptoms of menopause, such as hot flashes and night sweats. But such treatments can increase the risk of cardiovascular complications, so women with heart problems need non-hormonal options. Lynkuet is a small molecule designed to inhibit two targets: NK1 and NK3 receptors, which play a role in physiological processes such as regulating body temperature. Lynkuet's dual-targeting approach sets it apart from Astellas' Veozah, an NK3 receptor-blocking drug that was approved by the FDA in 2023.
Lynkuet also has safety advantages over Astellas menopause drugs. Last fall, the FDA issued a safety advisory about Veozah after a patient developed signs and symptoms of liver injury after taking it daily for about 40 days. In December, the FDA added a boxed warning to product labels to flag these risks.
In a January interview, Astellas Chief Medical Officer Tadaaki Taniguchi said liver toxicity was a known risk identified in clinical testing. He added that such risks are rare and “we believe the risk/return balance is indeed positive.” Astellas's fiscal 2024 sales were 33.8 billion yen (about $220 million). Astellas expects sales to reach 50 billion yen (approximately US$330 million) in fiscal 2025.
Lynkuet was originally developed by KaNDy Therapeutics. When Bayer acquired the women's health company in 2020, the drug was ready for Phase 3 testing. The efficacy of Lynkuet was evaluated in two placebo-controlled Phase 3 studies. Results showed the drug met its primary goal of reducing the frequency and severity of hot flashes measured at weeks 4 and 12.
The third phase 3 study evaluated the drug over one year, with the primary goal of assessing safety. Side effects reported in studies include headache, fatigue, dizziness and drowsiness. There is no boxed warning on Lynkuet's label, but the prescribing information instructs clinicians to conduct blood tests to detect liver function and damage before patients start taking the drug, and then conduct follow-up tests three months later.
“Hot flashes, especially when severe, can impact a woman's daily life, and this approval provides health care providers with a new treatment option for first-line treatment of moderate to severe hot flashes caused by menopause,” Dr. JoAnn Pinkerton, professor and director of midlife health at UVA Health and principal investigator of the drug's OASIS 2 Phase 3 clinical trial, said in a prepared statement.
In Friday's Lynkuet approval announcement, Bayer said it expected the new menopause drug to be available to U.S. patients in November. It has been approved in Australia, Canada, the UK and Switzerland. Lynkuet remains under regulatory scrutiny in the EU and other global markets.
Photo: Krisztian Bocsi/Bloomberg via Getty Images
