FDA accepts new drug application for nonhormonal hot flash drug elinzanetant

Key takeaways:

• FDA accepted a new drug application for nonhormonal elinzanetant to treat hot flashes associated with menopause.
• If approved, elinzanetant would be the second nonhormonal option for menopausal women.

The FDA accepted a new drug application for elinzanetant, a nonhormonal treatment for moderate to severe vasomotor symptoms associated with menopause, according to an industry press release.

Elinzanetant (Bayer) is the first dual neurokinin-1 and 3 receptor antagonist in late-stage clinical development for the nonhormonal treatment of moderate to severe hot flashes associated with menopause and is administered orally once daily. Data from three phase 3 studies suggest elinzanetant, compared with placebo, reduced hot flash frequency and severity for short- and long-term durations, improved sleep disturbances caused by menopause and improved menopause-related quality of life.

“The NDA acceptance of elinzanetant by the FDA marks a significant milestone in our efforts to advance menopause care for women in the U.S.,” Christine Roth, executive vice president of global product strategy and commercialization at Bayer, said in the release. “If approved, elinzanetant will offer a new nonhormonal option to women seeking treatment for moderate to severe vasomotor symptoms and we look forward to the review by the agency.”

If approved, elinzanetant would be the second nonhormonal drug for the treatment of moderate to severe hot flashes; the FDA approved the first neurokinin 3 receptor antagonist, fezolinetant (Veozah, Astellas Pharma), in May 2023.

The application is based on positive data from the phase 3 OASIS 1, 2 and 3 studies. Findings from OASIS 1 and 2, published in August in JAMA, demonstrated that elinzanetant reduced hot flash frequency and severity at weeks 4 and 12 compared with placebo; women also reported improved sleep and menopause-related quality of life. OASIS 3 data, presented at the Annual Meeting of The Menopause Society in September, demonstrated that postmenopausal women taking elinzanetant reported fewer daily moderate to severe hot flashes for up to 50 weeks vs. placebo.

Other studies of elinzanetant are still ongoing. The OASIS 4 study is an expansion of the clinical phase 3 program and investigates the efficacy and safety of elinzanetant in women with moderate to severe hot flashes caused by endocrine therapy for treatment or prevention of breast cancer.

In addition to the OASIS program, Bayer is conducting NIRVANA, an exploratory phase 2 study to explore the efficacy of elinzanetant on sleep disturbances associated with menopause as determined by polysomnography.

In the release, Bayer stated it is continuing to submit applications for marketing authorizations of elinzanetant to other health authorities.