Bayer AG, a prominent German pharmaceutical company, has publicly announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for elinzanetant, an investigational compound. This application seeks approval for the use of elinzanetant in treating moderate-to-severe vasomotor symptoms (VMS), commonly referred to as hot flashes, associated with menopause.
Upon approval, elinzanetant will provide women with a new, non-hormonal option for managing these menopausal symptoms. The NDA submission is supported by positive outcomes from the Phase III clinical studies, OASIS 1, 2, and 3, which assessed the efficacy and safety of elinzanetant compared to a placebo.
In addition to the U.S., Bayer is actively pursuing marketing authorization applications for elinzanetant with other global health authorities.