Bayer announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has authorized elinzanetant, the first dual neurokinin (NK-1 and NK-3 receptor) antagonist, under the brand name Lynkuet (Lynkuet in UK), for the treatment of moderate to severe vasomotor symptoms (VMS), also known as hot flashes, associated with menopause. 

“This first approval marks an important milestone for our hormone-free treatment elinzanetant,” said Christine Roth, EVP, Global Product Strategy and Commercialization at Bayer. “It reflects Bayer’s commitment to advancing women’s health, and we look forward to making this option available in more countries.” 

“Menopausal symptoms like hot flashes can significantly impact women’s quality of life,” said Dr. Paula Briggs, Consultant Gynaecologist, Liverpool Women’s NHS Foundation Trust. “Having a new hormone-free treatment gives physicians another option to tailor care based on individual needs.” 

The UK authorization is based on positive results from the Phase III OASIS-1, -2, and -3 trials, which evaluated the efficacy and safety of elinzanetant. Elinzanetant met all primary endpoints across all studies and showed a favorable safety profile. 

In OASIS-1 and -2, elinzanetant significantly reduced the frequency and severity of moderate to severe VMS at weeks 4 and 12 versus placebo. Over 80% of participants saw at least a 50% reduction in VMS frequency by week 26. The studies also met all three key secondary endpoints: reductions in VMS from baseline to week 1, and improvements in sleep and menopause-related quality of life.

In OASIS-3, elinzanetant showed significant reduction in VMS at week 12 versus placebo, with benefits maintained over the 52-week study. The most common side effects were headache, fatigue, and drowsiness. 

Following these results, Bayer has submitted applications for elinzanetant in the US, EU, and other global markets.