On Tuesday, Bayer AG (OTC:BAYRY) submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for elinzanetant for moderate to severe vasomotor symptoms (VMS, also known as hot flashes) associated with menopause or caused by adjuvant endocrine therapy.
The EMA submission is based on Phase 3 development program OASIS results.
OASIS 1 and 2 data were published in the Journal of the American Medical Association (JAMA) in August.
Detailed results of the Phase 3 study OASIS 3, which provided additional efficacy and safety data over 52 ...
