Bayer's Lynkuet Gains FDA Approval, Expanding Nonhormonal Menopause Treatment Options

Bayer has secured FDA approval for Lynkuet (elinzanetant), a novel nonhormonal treatment for moderate to severe vasomotor symptoms associated with menopause. This approval marks a significant expansion in the limited arsenal of nonhormonal options available to menopausal women in the United States.

Lynkuet: A Dual Neurokinin Targeted Therapy

Lynkuet is a dual neurokinin (NK) targeted therapy that aims to alleviate hot flashes and night sweats, two of the most common and distressing symptoms of menopause. The drug works by targeting both NK1 and NK3 receptors in the brain, which play a crucial role in temperature regulation.

Administered as a soft gel capsule taken once daily at bedtime, Lynkuet offers a convenient treatment option for women seeking relief from menopausal symptoms. The FDA approval follows successful outcomes in three late-stage clinical trials, known as Oasis 1, Oasis 2, and Oasis 3.

In the Oasis 1 and Oasis 2 studies, Lynkuet demonstrated significant reductions in both the frequency and severity of moderate to severe hot flashes compared to placebo at the four- and 12-week marks. Notably, more than 80% of patients receiving Lynkuet achieved at least a 50% reduction in vasomotor symptom frequency by Week 26. The trials also showed statistically significant improvements in sleep disturbances and menopause-related quality of life measures.

Market Implications and Competition

Bayer plans to launch Lynkuet in the U.S. market next month, positioning it as a direct competitor to Astellas' Veozah, another nonhormonal menopause symptom drug that targets NK3 receptors. Veozah received FDA approval in May 2023 but currently carries a black box warning for potential liver damage, which Lynkuet does not have.

The approval of Lynkuet expands the limited options available for nonhormonal menopause treatments in the U.S., which previously included Veozah and Brisdelle, a reformulation of the antidepressant paroxetine approved for hot flashes in 2013.

Bayer projects peak annual sales for Lynkuet to reach 1 billion euros ($1.16 billion). In contrast, Astellas' Veozah generated sales of 33.8 billion Japanese yen (approximately $221.25 million) in the 2024 Japanese fiscal year, falling short of the company's projections.

Global Expansion and Market Potential

Lynkuet has already received regulatory approvals in the United Kingdom, Australia, Canada, and Switzerland, with ongoing reviews in the European Union and other jurisdictions. This global expansion comes at a time when the menopause treatment market is poised for significant growth.

Bayer estimates that by 2030, the global population of women experiencing menopause will increase to 1.2 billion, with approximately 47 million women entering this stage of life each year. Up to 80% of women report experiencing hot flashes during the menopausal transition, with more than one-third reporting severe symptoms that can persist for a decade or more after their last menstrual period.