Bayer's Lynkuet Gains FDA Approval, Expanding Non-Hormonal Options for Menopausal Symptoms
The U.S. Food and Drug Administration (FDA) has approved Bayer's Lynkuet (elinzanetant) for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. This approval marks a significant advancement in non-hormonal therapies for menopausal women, offering a new alternative to existing treatments.
A Novel Dual-Action Mechanism
Lynkuet is the first FDA-approved therapy that targets both neurokinin 1 (NK1) and neurokinin 3 (NK3) receptors. This dual-action mechanism is designed to regulate body temperature and reduce the frequency and severity of hot flashes. The once-daily oral medication, taken as a soft gel capsule before bedtime, represents a new approach to managing one of the most common and disruptive symptoms of menopause.
Clinical Efficacy and Safety Profile
Bayer's approval was supported by a robust clinical development program, including the Phase III OASIS trials. Key findings from these studies include:
- OASIS 1 and 2 demonstrated significant reductions in VMS, with improvements of 55.9% to 67% observed at weeks 4 and 12.
- Over 80% of patients achieved at least a 50% reduction in VMS frequency by week 26.
- OASIS 3 confirmed Lynkuet's long-term safety and efficacy through 52 weeks of follow-up.
The most common side effects reported were headache, fatigue, dizziness, and drowsiness. While Lynkuet's label includes warnings for daytime impairment and potential pregnancy loss, it notably does not carry a black box warning for liver damage, unlike its competitor Veozah.
Market Implications and Availability
Lynkuet is set to enter a growing market for non-hormonal menopause treatments, competing directly with Astellas Pharma's Veozah, which was approved in 2023. Bayer plans to launch Lynkuet in the U.S. in November 2025, with a wholesale acquisition cost of $625 for a 30-day supply.
Christine Roth, Bayer's executive vice president of global product strategy and commercialization, emphasized the drug's importance, stating, "There is a need for more individualized approaches to menopause care, and Lynkuet addresses a significant gap in treatment options."
As the global population of menopausal women is projected to reach 1.2 billion by 2030, with 47 million women entering menopause each year, Bayer anticipates peak annual sales for Lynkuet could reach 1 billion euros ($1.16 billion).
References
- Bayer Gets FDA Nod for Novel Drug to Treat Hot Flashes
Lynkuet is the first FDA-approved therapy that blocks both the neurokinin 1 and neurokinin 3 receptors to treat hot flashes.
- Bayer receives FDA approval for non-hormonal menopause therapy
Clearance of Lynkuet provides a new alternative to hormone-based treatment for hot flashes and sets up a market battle with Astellas Pharma’s Veozah.
- With FDA nod, Bayer's Lynkuet enters US market for nonhormonal menopause symptom meds
Following a slight delay earlier this year—and a world-first green light in the U.K. over the summer—Bayer has clinched an FDA nod to bolster the limited arsenal of nonhormonal treatments for one of the most common symptoms of menopause.
Explore Further
What distinguishes Lynkuet's dual-action mechanism targeting NK1 and NK3 receptors from traditional hormonal therapies for menopausal symptoms?
What were the primary endpoints used in the OASIS clinical trials to measure Lynkuet’s efficacy and safety?
How does Lynkuet’s side effect profile compare to its main competitor, Veozah, approved in 2023?
What factors contributed to Bayer's decision to set the wholesale acquisition cost of Lynkuet at $625 for a 30-day supply?
How does Bayer plan to achieve its projected annual sales of 1 billion euros for Lynkuet given the existing competition in the non-hormonal menopause treatment market?