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Elinzanetant Update: FDA Accepts Bayer NDA, Sets July 2025 PDUFA Date
The elinzanetant NDA is based on data, including long-term efficacy, from the OASIS phase 3 clinical trial program, according to Bayer.
The FDA this week accepted Bayer’s New Drug Application (NDA) for elinzanetant, an investigational non-hormonal treatment for moderate-to-severe vasomotor symptoms (VMS) associated with menopause, the company announced in a news release.1 The once-daily oral therapy is the first dual neurokinin-1 and -3 receptor antagonist in late-stage clinical development.
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“The NDA acceptance of elinzanetant by the FDA marks a significant milestone in our efforts to advance menopause care for women in the US,” Christine Roth, executive vice president, global product strategy and commercialization, and member of the pharmaceutical leadership team at Bayer, said in the release.1 “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.”1
The FDA has set a Prescription Drug User Fee Act date for July 26, 2025.
Positive data from the phase 3 OASIS 1, 2, and 3 clinical trials form the foundation supporting the NDA, all 3 studies designed to evaluate the efficacy and safety of elinzanetant compared with placebo.
Findings from the OASIS 1 (n = 309) and 2 (n = 324) pivotal phase 3 trials were published in JAMA in August.2 The randomized, double-blind, placebo-controlled studies enrolled postmenopausal women aged 40 to 65 years experiencing moderate to severe VMS. Participants in the elinzanetant arm received a 120 mg dose of elinzanetant once daily for 26 weeks. Women in the control arm received a matching placebo once daily for 12 weeks, followed by elinzanetant 120 mg for 14 weeks.2
The dual primary endpoint was mean change in frequency and severity of moderate-to-severe VMS from baseline to weeks 4 and 12; secondary endpoints were change in sleep quality and overall quality of life related to menopause. The frequency and severity of VMS were comparable between the groups at baseline, according to Bayer. Elinzanetant reduced both VMS frequency and severity at week 4 and week 12. In addition, investigators reported statistically significant changes at week 12 in the 2 key secondary endpoints, ie, decreased sleep disturbance and improvement in menopause-related quality of life, compared to placebo.2
OASIS 3 investigated the efficacy and safety of elinzanetant for the treatment of VMS over 52 weeks.3 Bayer originally announced findings at the 2024 annual meeting of The Menopause Society in September. The long-term safety trial enrolled 628 postmenopausal women between ages 40 and 65 years who were randomly assigned to intervention (elinzanetant 120 mg/day) and control (placebo) groups. Consistent with findings from OASIS 1 and OASIS 2, OASIS 3 showed that elinzanetant effectively reduced the frequency of moderate-to-severe VMS from baseline to week 12 compared to placebo.3 Demonstrating the long-term efficacy of elinzanetant, VMS reductions were maintained throughout the 52-week duration of the trial as were the improvements in measures of sleep disturbance and menopause-related QoL.3
“The detailed results of OASIS 3 are complementing the positive results of OASIS 1 and 2, addressing the question on its long-term profile and indicating the potential of elinzanetant to treat moderate to severe VMS associated with menopause,” Christian Rommel, global head of research and development at Bayer AG’s Pharmaceuticals Division, said in a September news release.3 “We look forward to continuing our discussions with health authorities around the world regarding marketing authorizations for this compound.”3
The OASIS 4 study expands the phase 3 OASIS clinical trial program and is investigating the efficacy and safety of elinzanetant in women with moderate-to-severe VMS caused by endocrine therapy for treatment or prevention of breast cancer, according to the news release.1
Beyond the OASIS program, Bayer is conducting NIRVANA (NCT06112756), an exploratory phase 2 randomized, parallel-group treatment, double-blind study exploring the efficacy of elinzanetant on sleep disturbances associated with menopause as determined by polysomnography.1
Up to 80% of women experience VMS at some point during menopause, and by 2030, the global population of women in menopause is expected to reach 1.2 billion, with 47 million women entering this phase annually.1
But despite the impact of menopausal symptoms on their health, “less than 15% of women are being treated, and it's an issue on both sides," OASIS 1 and 2 lead investigator JoAnn Pinkerton, MD, said in a recent interview with Patient Care.5 The 2 sides she refers to are women and their health care professionals. "Women do not need to suffer in silence,” Pinkerton stresses, pointing to clinician hesitancy and patient perceptions about the safety of different treatment options as barriers to effective care.5
