Bayer: FDA accepts NDA application

(CercleFinance.com) - Bayer has announced that the US FDA has accepted the New Drug Application (NDA) for the investigational compound elinzanetant for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) associated with menopause.


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

The FDA's acceptance of elinzanetant marks an important milestone in our efforts to advance menopause care for women in the United States, Bayer said.

Bayer continues to submit marketing authorization applications for elinzanetant to other health authorities.


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