Bayer's Lynkuet Gains First Worldwide Approval for Hormone-Free Menopause Treatment in UK

Bayer has secured its first global approval for Lynkuet (elinzanetant), a novel hormone-free treatment for menopausal symptoms, from the UK's Medicines and Healthcare products Regulatory Agency (MHRA). This milestone comes two years after Astellas introduced the first nonhormonal therapy in this space, marking a significant advancement in menopause management.

A New Era in Menopause Treatment

Lynkuet, an oral medication, is designed to alleviate moderate to severe vasomotor symptoms associated with menopause, including hot flashes and night sweats. The MHRA has also recognized its potential to improve sleep issues commonly experienced during menopause.

Unlike traditional hormone replacement therapies used since the 1960s, Lynkuet offers a hormone-free alternative. It acts as a dual-action neurokinin antagonist, targeting both NK-3 and NK-1 receptors, distinguishing it from Astellas' Veozah, which solely targets NK-3 receptors.

Dr. Paula Briggs, a gynecologist at Liverpool Women's NHS Foundation Trust, emphasized the impact of this approval: "Menopausal symptoms, such as hot flashes, can have a profound impact on the quality of life for women. They are not just physical discomforts; they can significantly disrupt daily activities, sleep and emotional well-being. Physicians now have a new hormone-free treatment option that offers an alternative for tailoring treatment plans."

Clinical Efficacy and Future Prospects

Lynkuet's approval is supported by three successful phase 3 studies, each meeting their primary endpoints. In two of these trials, over 80% of participants in the treatment arm experienced at least a 50% reduction in hot flashes compared to the placebo group over 26 weeks.

Bayer has already submitted applications for elinzanetant in Europe and the United States, with the FDA expected to make a decision by July 26. The company has also tested Lynkuet in a trial involving 474 breast cancer patients, yielding results similar to those observed in menopause trials. This could potentially expand the drug's application to breast cancer patients who often experience menopause-like symptoms due to hormone-suppressing treatments.

As the menopause treatment landscape evolves, Bayer's Lynkuet joins Astellas' Veozah in offering nonhormonal options to the estimated 80% of women who experience vasomotor symptoms during menopause. With only about a third of affected women currently receiving treatment, these new therapies may significantly impact menopause management and improve quality of life for millions of women worldwide.