Bayer menopause drug wins FDA approval, bringing competition to an Astellas product

A Bayer drug that hits two central nervous system targets to treat moderate to severe menopausal symptoms has received FDA approval, introducing a new non-hormonal treatment option that could 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 to take once daily before bedtime. Bayer will market this new menopause drug under the Lynkuet brand.

Hormonal therapies are standard treatment for vasomotor symptoms of menopause, such as hot flashes and night sweats. But these treatments can increase the risk of cardiovascular complications. Women with heart problems therefore need non-hormonal options. Lynkuet is a small molecule designed to inhibit two targets, the NK1 and NK3 receptors, both of which play a role in regulating physiological processes such as body temperature. Lynkuet’s dual-targeting approach differentiates it from Astellas’ Veozah, an NK3 receptor-blocking drug that won FDA approval in 2023.

Lynkuet may also have a safety advantage over menopause drug Astellas. Last fall, the FDA issued a communication about the safety of Veozah after a patient who took the pill once a day for about 40 days developed signs and symptoms of liver damage. Last December, the FDA added a black box warning to the product label warning of these risks.

In a January interview, Astellas Chief Medical Officer Tadaaki Taniguchi said liver toxicity is a known risk that has been identified in clinical trials. He added that this risk is rare and “we think the risk/benefit balance is really positive.” For fiscal 2024, Astellas reported revenue of 33.8 billion Japanese yen (approximately $220 million). For fiscal 2025, Astellas forecasts revenue of 50 billion yen (about $330 million).

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. Lynkuet’s effectiveness was evaluated in two placebo-controlled phase 3 studies. Results showed that the drug achieved the primary 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 the primary objective of assessing safety. Side effects reported in studies included headache, fatigue, dizziness and drowsiness. Lynkuet’s label does not have a black box warning, although the prescribing information instructs clinicians to perform blood tests to test liver function and damage before a patient begins taking the drug, then a follow-up test three months later.

“Hot flashes, especially when severe, can impact women’s daily lives and this approval provides healthcare providers with a new treatment option that can be used as a first-line treatment for moderate to severe hot flashes due to menopause,” said Dr. JoAnn Pinkerton, professor and director of midlife health at UVA Health and principal investigator of the Phase 3 clinical trial. OASIS 2 of the drug, in a prepared press release.

In Friday’s Lynkuet approval announcement, Bayer said it expects the new menopause drug to be available to U.S. patients in November. It is already approved in Australia, Canada, the United Kingdom and Switzerland. Lynkuet remains under regulatory review in the European Union and other global markets.

Photo: Krisztian Bocsi/Bloomberg, via Getty Images