FDA accepts New Drug Application for elinzanetant
The New Drug Application (#NDA) for #elinzanetant, an investigational compound for the treatment of moderate to severe vasomotor symptoms associated with #menopause, is based on the positive data from three Phase III studies OASIS. Elinzanetant is the first dual #neurokinin-1 and 3 (NK-1 and 3) receptor antagonist, in late-stage clinical development for the non-hormonal treatment of moderate to severe VMS associated with menopause, administered orally once daily.
“The NDA acceptance of elinzanetant by the #FDA marks a significant milestone in our efforts to advance menopause care for women in the U.S.,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization, Member of the #Pharmaceutical Leadership Team at Bayer. “If approved, elinzanetant will offer a new non-hormonal option to women seeking treatment for moderate to severe vasomotor symptoms and we look forward to the review by the agency."
The NDA application is based on the positive results from the OASIS 1, 2 and 3 Phase III studies evaluating the efficacy and safety of the investigational compound elinzanetant versus placebo. Findings from OASIS 1 and 2 were published in August 2024 in JAMA.0F1 Detailed results of the Phase III study OASIS 3 providing supporting efficacy and additional long-term safety data were presented at The Menopause Society (TMS) annual meeting in September 2024.