Two years after Astellas hit the market with a nonhormonal therapy for menopause, Bayer has followed suit, scoring its first worldwide nod for a similar hormone-free treatment.
The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) has signed off on Bayer’s Lynkuet (elinzanetant), an oral therapy to relieve moderate to severe vasomotor symptoms (hot flashes and night sweats) that accompany menopause. Lynkuet can also improve sleep issues that often come with menopause, the regulator said.
The common menopause symptoms are caused by a fluctuation in hormone levels that affect the body’s temperature regulation. Bayer's and Astellas' drugs are alternatives to hormone replacement therapies that have been used to treat menopause since the 1960s. While vasomotor symptoms affect up to 80% of women during menopause, only about a third of them receive treatment, Bayer said.
While Astellas’ Veozah was the first neurokinin 3 (NK-3) receptor antagonist approved for menopause, Lynkuet is the first dual-action neurokinin in the indication, targeting the NK-3 and NK-1 receptors, Bayer noted in an approval announcement.
“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,” Paula Briggs, M.D., a gynecologist at Liverpool Women’s NHS Foundation Trust, said in Bayer's release. “Physicians now have a new hormone-free treatment option that offers an alternative for tailoring treatment plans.”
Three phase 3 studies that each achieved their primary endpoints set up Lynkuet for the U.K. green light. In each trial, Lynkuet reduced the frequency and severity of moderate to severe vasomotor symptoms. In two of the trials, more than 80% of those in the treatment arm saw at least a 50% reduction in hot flashes compared to those on placebo through 26 weeks, Bayer said.
The German drugmaker has submitted applications for the review of elinzanetant in Europe and the U.S., where the FDA has set a target decision date of July 26.
Bayer also has tested Lynkuet in a trial of 474 breast cancer patients, with the results mirroring those in the menopause trials. Breast cancer patients often experience menopause symptoms because of the hormone-suppressing treatments they receive.
As for Astellas' hot flash drug, the Japanese company in April reported 2024 fiscal year sales of Veozah at 33.8 billion yen ($230 million), which came up short of its expectations. Astellas has projected fiscal 2025 sales at 50 billion yen ($340 million). The company's peak sales projection for the treatment is $3.6 billion.