Bayer Files NDA With U.S. FDA For Elinzanetant To Treat Moderate To Severe Menopausal Symptoms

(RTTNews) - Bayer said that a New Drug Application or NDA for the investigational compound elinzanetant has been submitted to the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) associated with menopause.

The submission is based on positive results from the OASIS 1, 2 and 3 Phase III studies evaluating the efficacy and safety of the investigational compound elinzanetant versus placebo.

Bayer noted that it will submit applications for marketing authorizations of elinzanetant for the treatment of moderate to severe VMS associated with menopause to other health authorities as well.

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