Bayer's Lynkuet Secures FDA Approval, Expanding Nonhormonal Options for Menopause Symptoms
Bayer has received FDA approval for Lynkuet (elinzanetant), a new nonhormonal treatment for moderate to severe vasomotor symptoms associated with menopause. This approval marks a significant expansion of options for women seeking relief from hot flashes and night sweats without the risks associated with hormone therapy.
Lynkuet: A Dual-Action Approach to Menopause Symptom Relief
Lynkuet, a once-daily soft gel capsule taken at bedtime, targets both NK1 and NK3 receptors in the brain, which are involved in temperature regulation. This dual-action mechanism distinguishes it from Astellas' Veozah, approved in May 2023, which targets only NK3 receptors.
The FDA's decision was based on three late-stage studies, including Oasis 1 and Oasis 2, which demonstrated significant reductions in the frequency and severity of moderate to severe hot flashes compared to placebo at four and 12 weeks. By week 26, over 80% of patients receiving Lynkuet achieved at least a 50% reduction in vasomotor symptom frequency.
Market Impact and Competition
Bayer plans to launch Lynkuet in the U.S. next month, entering a market with limited nonhormonal options. The drug will compete directly with Astellas' Veozah and Brisdelle, a reformulation of the antidepressant paroxetine approved for hot flashes in 2013.
Notably, Lynkuet does not carry a black box warning for potential liver damage, which could give it an advantage over Veozah. However, Bayer has cautioned about potential side effects, including daytime impairment and increased liver blood test values.
Claire Gill, president and founder of the National Menopause Foundation, highlighted the importance of expanding treatment options for women experiencing menopausal symptoms. Bayer projects peak annual sales for Lynkuet could reach 1 billion euros ($1.16 billion).
Global Expansion and Market Potential
Prior to its U.S. approval, Lynkuet received clearance in the UK, Australia, Canada, and Switzerland. The drug is currently under review in the EU and other jurisdictions. This global expansion comes as Bayer estimates the worldwide population of menopausal women will increase to 1.2 billion by 2030, with 47 million women entering menopause annually.
As the pharmaceutical industry continues to address the growing demand for menopause treatments, Lynkuet's approval represents a significant step forward in providing effective, nonhormonal options for millions of women worldwide.
References
- 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 were the specific endpoints measured in the Oasis 1 and Oasis 2 clinical trials for Lynkuet?
How does Lynkuet's dual-action mechanism targeting NK1 and NK3 receptors compare to Veozah's single-action mechanism targeting NK3 receptors?
What are the expected market dynamics or challenges for Lynkuet competing against Veozah and Brisdelle in the nonhormonal menopause treatment market?
How does the absence of a black box warning for liver damage provide a competitive advantage to Lynkuet over other treatments like Veozah?
What is the projected growth rate of the global menopause treatment market as the world's population of menopausal women increases to 1.2 billion by 2030?