Bayer's Lynkuet Gets FDA Nod for Menopausal Hot Flashes

The U.S. Food and Drug Administration (FDA) has given approval to Lynkuet (elinzanetant), Bayer's dual neurokinin (NK) receptor antagonist that is not accompanied by the use of hormones and is the first treatment of moderate to severe vasomotor symptoms (VMS), i.e., hot flashes, connected with menopause, to be used.

Lynkuet works by blocking the NK1 and NK3 receptors on KNDy neurons, which leads to the inhibition of Substance P and Neurokinin B. At the same time, the brain's thermoregulatory pathways that cause the frequency and intensity of hot flashes are normalized as a result of the regulation by KNDy neurons.

The U.S. Food and Drug Administration (FDA) approval is derived from the Phase III OASIS 1, OASIS 2, and OASIS 3 clinical trials that tested the efficacy and safety profile of Lynkuet. In these pivotal studies, elinzanetant reduced the occurrence and also the intensity of hot flashes significantly by weeks 4 and 12 when comparing the treated and placebo groups with the continuation of the benefits and safety being confirmed during the 52 weeks of the OASIS 3 trial.

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"This approval is a major milestone in Bayer's women's health portfolio over the last 100 years," says Christine Roth, Executive Vice President, Global Product Strategy and Commercialization at Bayer. "With Lynkuet around, a hormone-free choice is available to women who want tailored menopause care."

Lead investigator, Dr. JoAnn Pinkerton of UVA Health, shared that the therapy presents an effective, tolerable, and first-line approach for women suffering from hot flashes and, thus, has the potential to significantly raise the quality of life during ‍menopause.