Bayer submits New Drug Application to USFDA for Elinzanetant for treatment of moderate to severe vasomotor symptoms associated with menopause
Berlin: Bayer has announced that a New Drug Application (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 the positive results from the Phase III OASIS 1, 2 and 3 studies.
“Half of the world’s population will experience menopause, with 27 million women in the U.S. currently experiencing this transition. Despite the impact menopausal symptoms may have on women’s health and quality of life, many go without treatment due to gaps in awareness, education, and limitations of treatment options available”, said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization, Member of the Pharmaceutical Leadership Team at Bayer. “The FDA submission for elinzanetant marks a significant milestone in our efforts to offer a new non-hormonal option for women. This further underscores our position as leaders in Women's Health and our dedication to addressing the unmet medical needs of women globally.”
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. Findings showed that elinzanetant (120 mg orally once daily) significantly reduced the frequency and severity of moderate-to-severe VMS and demonstrated a favorable safety profile with headache and fatigue being the most frequent treatment emergent adverse events (TEAEs) within the elinzanetant groups. Consistent improvements were also seen across OASIS 1 and 2 in all three key secondary endpoints, with significant reduction in frequency of VMS at week 1, improvement in sleep disturbances a and menopause-related quality of life.
The full results of OASIS 1 and 2 were recently presented at the 2024 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical & Scientific Meeting. Positive topline results for the Phase III study OASIS 3 were announced in March 2024, providing additional supporting efficacy data as well as safety data of elinzanetant over 52 weeks, with details being presented at an upcoming scientific meeting.
Hot flashes are among the most frequently reported symptoms of menopause, a transitional phase in a woman’s life expected to affect 1.2 billion women worldwide by 2030. Hot flashes have also been shown to negatively impact women’s quality of life and are one of the leading causes for women to seek medical attention. It is important that additional options become available to give women a choice on how to address these symptoms.
Bayer 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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