Bayer Seeks EMA Approval for Elinzanetant to treat vasomotor symptoms

The biotechnology firm Bayer has requested approval from the European Medicines Agency (EMA) for elinzanetant to treat moderate to severe vasomotor symptoms (VMS, commonly known as hot flashes) linked to menopause or triggered by adjuvant endocrine therapy by submitting a marketing authorization application (MAA).

“Menopausal symptoms can differ significantly from one woman to another in both their nature and intensity,” said Christine Roth, executive vice president, global product strategy and commercialization, member of the pharmaceutical leadership team at Bayer. “With this submission, Bayer is seeking to expand treatment choices so that clinicians can offer more personalized care that addresses the unique needs of each woman.”

The submission to the EMA is grounded on findings from the OASIS phase III development program. Information from OASIS 1 and 2 was released in the Journal of the American Medical Association (JAMA) in August 2024. In September 2024, The Menopause Society (TMS) annual meeting showcased in-depth findings from the phase III study OASIS 3, offering extended efficacy and safety analyses spanning 52 weeks.

The Health Authorities in Australia, Canada, Switzerland, UK, and the US have all approved the company's New Drug Applications (NDAs) for elinzanetant for evaluation. The top pharmaceutical company is still applying for marketing approvals for elinzanetant with additional health agencies worldwide.