Bayer Submits NDA to FDA for Elinzanetant for Treatment of VMS

Bayer submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for elinzanetant for the treatment of moderate-to-severe vasomotor symptoms (VMS) associated with menopause, according to a company press release.

The submission is based on the positive results from the phase 3 OASIS 1, 2, and 3 clinical trials that examined the efficacy and safety of elinzanetant 120 mg taken orally once a day compared to placebo. Findings from all 3 studies showed that elinzanetant significantly reduced the frequency and severity of moderate-to-severe VMS. Also, results from all 3 studies demonstrated a favorable safety profile, with headache and fatigue as the most frequent treatment emergent adverse events among participants who received elinzanetant, Bayer stated in the August 1, 2024, press release.

“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, Bayer, in the release. “The FDA submission for elinzanetant marks a significant milestone in our efforts to offer a new non-hormonal option for women.”

Elinzanetant is a novel dual neurokinin-1,3 (NK-1,3) receptor antagonist in late-stage clinical development for the nonhormonal treatment of moderate-to-severe VMS associated with menopause. Elinzanetant modulates estrogen-sensitive neurons associated with thermoregulatory pathway hyperactivation, according to the release.

The full results of OASIS 1 and 2 were recently presented at the 2024 American College of Obstetricians and Gynecologists annual meeting, held May 17-19, in San Francisco. In both studies, elinzanetant met all 3 key secondary endpoints: statistically significant reductions in VMS frequency from baseline to week 1 and improvement in both sleep disturbance and quality of life compared to placebo in postmenopausal women aged 40 to 65 years.

Positive topline results from OASIS 3 were announced in March 2024 and showed that elinzanetant was associated with statistically significant reduction in the frequency of moderate-to-severe VMS symptoms from baseline to week 12 compared to placebo.

The OASIS clinical development program also includes the OASIS 4 study, which aims to examine the efficacy and safety of elinzanetant in women with moderate-to-severe VMS caused by endocrine therapy for treatment or prevention of breast cancer, the manufacturer stated.

Along with the OASIS program, Bayer noted in the release it is conducting an exploratory phase 2 randomized, parallel-group treatment, double-blind study called NIRVANA (NCT06112756) to assess the efficacy of elinzanetant on sleep disturbances associated with menopause as determined by polysomnography.

The company plans to submit applications for marketing authorizations of elinzanetant to other health authorities, according to the release.

Reference: Bayer submits New Drug Application to U.S. FDA for elinzanetant for the treatment of moderate to severe vasomotor symptoms associated with menopause. News release. Bayer. August 1, 2024. Accessed August 6, 2024. https://www.bayer.com/en/us/news-stories/new-drug-application-to-us-fda-for-elinzanetant