Bayer Submits Marketing Authorization Application for Elinzanetant to Treat Menopausal Hot Flashes in Europe

Bayer AG has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for elinzanetant, a potential new treatment for moderate to severe vasomotor symptoms (VMS) associated with menopause. This follows the FDA’s acceptance of Bayer’s marketing application for elinzanetant last week. The EMA submission is based on positive results from the Phase 3 OASIS clinical trials, which demonstrated a statistically significant reduction in the frequency of hot flashes compared to placebo.

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