German drug maker Bayer announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for elinzanetant.
The oral once-daily investigational compound is intended to treat moderate-to-severe vasomotor symptoms (VMS), commonly known as hot flashes, related to menopause.
Elinzanetant is said to be the first dual neurokinin-1 and 3 (NK-1 and 3) receptor antagonist in late-stage clinical development.
Bayer submitted NDA in August based on positive results from the Phase 3 OASIS 1, 2 and 3 studies.
These trials evaluated the efficacy and safety of elinzanetant compared to a placebo.
Findings from OASIS 1 and 2 were published in August 2024. Detailed results from the OASIS 3 Phase 3 study, which provides supporting efficacy and additional long-term safety data, were presented in September.
The study results showed that the compound significantly reduced the frequency and severity of moderate-to-severe VMS.
It also demonstrated a favourable safety profile, with headache and fatigue being the most common treatment-emergent adverse events.
Consistent improvements were observed across OASIS 1 and 2 in all three key secondary endpoints. These included a significant reduction in VMS frequency by week one, improvements in sleep disturbances, and enhanced menopause-related quality of life.
Bayer pharmaceutical leadership team member and global product strategy and commercialisation executive vice president Christine Roth said: “The NDA acceptance of elinzanetant by the FDA marks a significant milestone in our efforts to advance menopause care for women in the US.
“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.”
The compound is also being assessed in the OASIS 4 study. It assesses the efficacy and safety of elinzanetant in women with moderate to severe VMS caused by endocrine therapy to treat or prevent breast cancer.
In addition to the OASIS programme, Bayer is conducting the NIRVANA study. It is an exploratory Phase 2 randomised, parallel-group, double-blind study.
The primary objective is to explore the efficacy of elinzanetant on sleep disturbances associated with menopause.
Bayer is submitting applications for marketing authorisation of elinzanetant to additional health authorities.
Recently, Bayer and US-based MOMA Therapeutics signed a collaboration for small molecule oncology therapeutics.
