Bayer: submit marketing authorization application to FDA

(CercleFinance.com) - Bayer announces that it has filed a New Drug Application (NDA) with the US FDA for elinzanetant in the treatment of moderate-to-severe vasomotor symptoms associated with menopause.


The NDA includes data from the Phase III OASIS 1, 2 and 3 studies - showing that elinzanetant significantly reduced the frequency and severity of moderate-to-severe vasomotor symptoms (MVS, also known as hot flushes) over 12 weeks compared to placebo.

80% of American women will experience hot flushes during the transition to menopause, with many remaining untreated.

Elinzanetant is the first dual neurokinin-1 and 3 (NK-1 and NK-3) receptor antagonist in late-stage clinical development for the non-hormonal treatment of moderate to severe VMS associated with menopause.

Half of the world's population will experience menopause, and 27 million women in the United States are currently undergoing this transition. Despite the impact menopausal symptoms can have on women's health and quality of life, many go untreated due to gaps in awareness, education and limitations in available treatment options, Bayer said.


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