What's Happening?
Bayer has announced that the U.S. Food and Drug Administration (FDA) has approved Lynkuet (elinzanetant) 60mg capsules for the treatment of moderate to severe hot flashes due to menopause. Lynkuet is the first and only dual neurokinin (NK) targeted therapy,
acting as a neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist. This approval is based on data from three Phase III clinical trials, known as OASIS 1, OASIS 2, and OASIS 3, which evaluated the safety and efficacy of Lynkuet. The trials demonstrated significant reductions in the frequency and severity of hot flashes. Lynkuet is administered as a soft gel capsule taken once daily at bedtime, with or without food.
Why It's Important?
The approval of Lynkuet provides a new treatment option for women experiencing moderate to severe hot flashes due to menopause, a common and often disruptive symptom. This development is significant as it expands the available options for managing menopause symptoms, offering a non-hormonal alternative. The introduction of Lynkuet could potentially improve the quality of life for many women, as hot flashes can significantly impact daily activities. Bayer's commitment to women's healthcare is further emphasized by their efforts to make Lynkuet accessible through the Lynkuet Access Savings & Support program, which aims to provide the medication at the lowest possible cost to patients.
What's Next?
Lynkuet is expected to be available in the U.S. starting November 2025. Bayer is also working to make Lynkuet accessible in other markets, with approvals already in place in Australia, Canada, the United Kingdom, and Switzerland, and pending approval in the European Union. The company is also offering support through the Bayer U.S. Patient Assistance Foundation for eligible patients who cannot afford their prescription. As Lynkuet becomes available, healthcare providers will have a new first-line treatment option for managing moderate to severe hot flashes due to menopause.
