Bayer Pursues EMA Approval for Menopause Symptom Treatment

Bayer has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for elinzanetant, aimed at treating moderate to severe vasomotor symptoms (VMS), commonly known as hot flashes, which are linked to menopause or caused by adjuvant endocrine therapy.

“Menopausal symptoms can vary greatly among women in both type and severity,” stated Christine Roth, Executive Vice President, Global Product Strategy and Commercialization, and Member of Bayer’s Pharmaceutical Leadership Team. "With this submission, Bayer aims to broaden treatment options so healthcare providers can deliver more personalized care that meets each woman's unique needs."

The EMA submission is supported by findings from the Phase III OASIS development program. Results from OASIS 1 and 2 were published in the Journal of the American Medical Association (JAMA) in August 2024, while detailed data from OASIS 3, demonstrating additional efficacy and safety over a 52-week period, were presented at The Menopause Society’s (TMS) annual meeting in September 2024.

Additionally, health authorities in Australia, Canada, Switzerland, the UK, and the US have recently accepted Bayer’s New Drug Applications (NDAs) for elinzanetant for review. Bayer continues to pursue marketing authorizations for the drug with other health authorities worldwide.