EU marketing authorization application is submitted for elinzanetant to treat moderate to severe vasomotor symptoms
Bayer has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for elinzanetant for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) associated with menopause or caused by adjuvant endocrine therapy
“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 EMA submission is based on results from the Phase III development program OASIS. Data from OASIS 1 and 2 were published in the Journal of the American Medical Association (JAMA)( previously cited) in August 2024. Detailed results of the Phase III study OASIS 3 providing additional efficacy and safety data over 52 weeks were presented at The Menopause Society (TMS) annual meeting in September 2024.
Recently, the Health Authorities in Australia, Canada, Switzerland, UK as well as in the US accepted the company’s New Drug Applications (NDAs) for elinzanetant for review. Bayer is continuing to submit applications for marketing authorizations of elinzanetant to further health authorities globally.
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