New Drug Application submitted to FDA for elinzanetant for the treatment of moderate to severe vasomotor symptoms 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. 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 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. About the OASIS 1, 2 and 3 studies.

OASIS 1 and 2 are double-blind, randomized, placebo-controlled multicenter studies investigating the efficacy and safety of elinzanetant administered orally once daily in women with moderate-to-severe VMS associated with menopause over 26 weeks. OASIS 1 and 2 randomized 396 and 400 postmenopausal women between 40 and 65 years across 184 sites in 15 countries. OASIS 3 is a double-blind, randomized, placebo-controlled multicenter study to investigate the efficacy and safety of elinzanetant for the treatment of vasomotor symptoms over 52 weeks in postmenopausal women. OASIS 3 randomized 628 postmenopausal women between 40 and 65 years across 83 sites in 9 countries.

About the Elinzanetant clinical development program : The Phase III clinical development program of elinzanetant, OASIS, currently comprises four Phase III studies: OASIS 1, 2, 3 and 4. The OASIS 1, 2 and 3 studies investigate the efficacy and safety of elinzanetant 120 mg in women with moderate to severe VMS associated with menopause. The OASIS 4 study is an expansion of the clinical Phase III program and investigates 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 design and dosing of the Phase III clinical development program is based on the positive data from two Phase II studies (RELENT-1 and SWITCH-1). RELENT-1 was a Phase Ib/IIa study investigating the safety, pharmacokinetics and preliminary efficacy of elinzanetant. SWITCH-1 was a Phase IIb study investigating the efficacy and safety of four different doses of elinzanetant compared to placebo in women with VMS.

In addition to the OASIS program, Bayer is conducting NIRVANA (NCT06112756), an exploratory Phase II randomized, parallel-group treatment, double-blind study. The primary objective is to explore the efficacy of elinzanetant on sleep disturbances associated with menopause as determined by polysomnography (PSG). PSG is a validated method to study sleep and underlying causes of sleep disturbances. Additional objectives include exploring the efficacy of elinzanetant on SDM as determined by patient-reported outcomes and further evaluating the safety of elinzanetant.