Bayer submits application to MHRA for elinzanetant to treat moderate to severe vasomotor systems associated with menopause in women

Reading, UK, 17^th September 2024 – Bayer has submitted a Marketing Authorisation Application (MAA) to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for the investigational compound elinzanetant for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flushes) associated with menopause in women. The submission is based on the positive results from the Phase III OASIS 1, 2 and 3 studies. 

"Menopause is a significant transition in a woman's life, affecting around 13 million women in the UK who are currently going through perimenopause or menopause, which accounts for almost a third of the female population.¹ Despite the impact menopausal symptoms may have on women’s health and quality of life, many go without treatment due to gaps in awareness, education, and limited treatment options," said Dr Joep Hufman, Country Medical Director, Bayer UK & Ireland. "The submission of elinzanetant to the MHRA represents a pivotal step in our efforts to offer a potential, alternative, non-hormonal treatment option for women, reinforcing our long-standing commitment to Women's Health in the UK."

The submission is based on positive results from the OASIS 1, 2 and 3 Phase III studies evaluating the efficacy and safety profile of the investigational compound elinzanetant (120mg orally once daily) in women with moderate to severe VMS associated with menopause versus placebo. Findings showed that elinzanetant significantly reduced the severity and frequency of moderate-to-severe VMS compared to placebo with headache and fatigue being the most frequently reported treatment emergent adverse events (TEAEs) within the elinzanetant groups in OASIS 1 and 2. Consistent improvements were also seen across OASIS 1 and 2 in all three key secondary endpoints, with significant reduction in frequency of VMS at week 1, improvement in sleep disturbances and menopause-related quality of life compared to placebo.

The full results of OASIS 1 and 2 were presented at the 2024 American College of Obstetricians and Gynaecologists (ACOG) Annual Clinical & Scientific Meeting in May and published in The Journal of the American Medical Association (JAMA)³ in August 2024. Positive results for the Phase III study OASIS 3 were presented last week at the 2024 Annual Meeting of The Menopause Society (TMS) as late-breaking data, confirming additional supporting efficacy data as well as safety data of elinzanetant over 52 weeks.

VMS, hot flushes, are among the most frequently reported symptoms of menopause, reported by up to 80% of women at some point during the menopausal transition.²Hot flushes have also been shown to negatively impact women’s quality of life and are one of the leading causes for seeking medical attention during this phase of a woman’s life.² Over one-third of menopausal women report severe symptoms, which can last 10 years or more after the last menstrual period.^4,5