Bayer's Elinzanetant Wins UK Approval for Menopause Hot Flashes

Bayer AG has announced that its novel drug, elinzanetant, has received approval from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of vasomotor symptoms (VMS), commonly known as hot flashes, associated with menopause. This marks the first global approval for elinzanetant, a first-in-class non-hormonal neurokinin-1,3 (NK-1,3) dual receptor antagonist, specifically for the treatment of hot flashes.

The approval is based on the results of three Phase III clinical trials: OASIS-1, OASIS-2, and OASIS-3. OASIS-1 and OASIS-2 were double-blind, randomized, placebo-controlled, multicenter studies designed to evaluate the efficacy and safety of elinzanetant administered once daily for 26 weeks in postmenopausal women experiencing moderate to severe VMS. These studies enrolled a total of 796 women aged 40 to 65 from 15 countries across 184 sites. OASIS-3 was a similar study that evaluated the efficacy and safety of elinzanetant over a 52-week period in 628 postmenopausal women aged 40 to 65 from 9 countries across 83 centers.

The results from these trials demonstrated that elinzanetant met all primary endpoints and showed a favorable safety profile. In the OASIS-1 and OASIS-2 studies, elinzanetant significantly reduced the frequency and severity of VMS compared to placebo. Additionally, elinzanetant achieved key secondary endpoints, showing a statistically significant reduction in VMS frequency from baseline to week 1, along with improvements in sleep disturbances and menopause-related quality of life. In the OASIS-3 study, elinzanetant significantly reduced VMS frequency from baseline to week 12, further confirming the results of the earlier trials and demonstrating sustained benefits and safety over 52 weeks.

This approval represents a significant milestone for Bayer, as it expands its portfolio of non-hormonal treatment options for menopausal symptoms. The company is continuing to pursue regulatory approvals for elinzanetant in the United States, the European Union, and other global markets. The successful outcomes of these clinical trials underscore the potential of elinzanetant as a novel therapeutic option for women experiencing menopausal symptoms, offering a non-hormonal alternative to existing treatments.