Bayer submits NDA for elinzanetant to treat vasomotor symptoms

Bayer submits NDA for elinzanetant to treat vasomotor symptoms | Image Credit: © lexiconimages - © lexiconimages - stock.adobe.com.

Bayer has submitted a New Drug Application for elinzanetant (BAY-3427080; Bayer) to treat moderate-to-severe vasomotor symptoms (VMS) in menopausal women.¹

This submission was based on positive safety and efficacy results from the phase 1, phase 2, and phase 3 OASIS studies. During the 2024 American College of Obstetricians and Gynecologists Annual Clinical & Scientific Meeting, full results of the OASIS 1 and OASIS 2 trials were presented, and positive topline results for OASIS 3 were reported in March 2023.

The topline OASIS 3 data indicated safety for over 52 weeks, alongside additional efficacy data. Details will be provided at a future scientific meeting.

VMS are caused by hyperactivation of a thermoregulatory pathway following a reduction in estrogen because of either reduced ovarian function during natural menopause or medical intervention such as bilateral oophorectomy or endocrine therapy.

Up to 80% of women experience VMS during the menopausal transition, with more than 1 in 3 reporting severe symptoms that can significantly impact quality of life. In some women, these symptoms can persist for over 10 years after the last menstrual period.

Elinzanetant is the first dual neurokinin-1 and 3 receptor antagonist developed to treat moderate-to-severe VMS in menopausal women. The drug is taken orally once per day, modulating estrogen sensitive neurons in the hypothalamus region of the brain that disrupt body heat control when hypertrophic. This may also reduce sleep disturbances caused by menopause.

The OASIS series includes 4 phase 3 trials: OASIS 1, OASIS 2, OASIS 3, and OASIS 4. The efficacy and safety of elinzanetant 120 mg in women with VMS linked to menopause were evaluated in the OASIS 1, 2, and 3 trials, while OASIS 4 is an expansion of the program evaluating the safety and efficacy in women with VMS linked to endocrine therapy.

The OASIS 1, 2, and 3 trials found significant reductions in the frequency and severity of moderate-to-severe VMS among patients receiving elinzanetant vs placebo. Secondary efficacy endpoints were also met, including a reduced frequency of VMS at week 1, less sleep disturbances, and improved menopause-related quality of life.

Headache and fatigue were reported as the most frequent treatment emergent adverse events. However, a positive safety profile for elinzanetant was observed overall.

Additionally, the efficacy of elinzanetant against sleep disturbances associated with menopause is being evaluated in NIRVANA (NCT06112756), an exploratory phase 2 randomized, parallel-group treatment, double-blind study. Sleep disturbances will primarily be assessed through polysomnography, but patient-reported outcomes will also be analyzed.

In an interview with Contemporary OB/GYN, JoAnn Pinkerton, MD, discussed the positive data observed in the OASIS 1 and OASIS 2 trials, including the improvements seen in hot flash frequency and severity at weeks 4 and 12.² The data indicated efficacy for treating hot flashes, sleep issues, and menopause-related mood issues.

Pinkerton also discussed how VMS will often impact women’s relationships at work and home, as well as their workplace productivity. Elinzanetant has shown promise for mitigating these adverse outcomes among women with contraindications to estrogen therapy such as estrogen-sensitive breast cancers, blood clots, and strokes.

Reference

1. Bayer submits New Drug Application to U.S. FDA for elinzanetant for the treatment of moderate to severe vasomotor symptoms associated with menopause. Bayer. August 1, 2024. Accessed August 1, 2024. https://www.bayer.com/en/us/news-stories/new-drug-application-to-us-fda-for-elinzanetant#:~:text=Berlin%2C%20August%201%2C%202024%20%E2%80%93,hot%20flashes)%20associated%20with%20menopause.
2. Krewson C. New data shows elinzanetant's efficacy in treating menopausal symptoms. May 18, 2024. Accessed August 1, 2024. https://www.contemporaryobgyn.net/view/new-data-shows-elinzanetant-s-efficacy-in-treating-menopausal-symptoms