Bayer Elinzanetant recommended for nod in EU for moderate to severe vasomotor symptoms
Berlin: Bayer has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended elinzanetant for marketing authorization in the European Union.
The compound is recommended as treatment of moderate to severe vasomotor symptoms (VMS; also known as hot flashes) associated with menopause or caused by adjuvant endocrine therapy (AET) related to breast cancer.
The final decision of the European Commission on the marketing authorization is expected within the coming months.
As per the company, if approved, elinzanetant would be the first dual neurokinin (NK)-targeted therapy (NK-1 and NK-3 receptor antagonist) approved in these two indications in the EU.
The compound is already approved under the brand name Lynkuet in Australia, Canada, the UK, and Switzerland for the treatment of VMS associated with menopause, and filings in other countries are underway or planned. Currently there are no approved treatments for menopause symptoms induced by endocrine therapy for breast cancer.
“Menopause is a truly individual experience, with symptoms and severity varying widely from woman to woman,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization, and Member of the Pharmaceutical Leadership Team at Bayer. “The positive CHMP opinion for elinzanetant marks a significant step forward in broadening treatment options for women across Europe. This milestone reflects our ongoing commitment to advancing innovative solutions that support better health outcomes and empower healthcare providers to offer more tailored care to meet the distinct needs of each woman.”
The CHMP opinion is based on positive results from the Phase III studies OASIS-1, -2, -3 and -4, evaluating the efficacy and safety profile of elinzanetant. Elinzanetant met all primary endpoints and key secondary endpoints in all four studies and demonstrated a favorable safety profile.
In OASIS-1 and -2, elinzanetant significantly reduced mean frequency and severity of moderate to severe VMS associated with menopause compared to placebo at weeks 4 and 12. Efficacy was maintained with over 80% of participants in the elinzanetant group achieving at least a 50% reduction in VMS frequency by week 26, including those who switched from placebo to elinzanetant after week 12. Both trials also achieved all three key secondary endpoints showing a statistically significant mean reduction in the frequency of VMS from baseline to week 1, as well as statistically significant improvements in sleep disturbances and menopause-related quality of life compared to placebo. Results from OASIS 1 and 2 were published in August 2024 in The Journal of the American Medical Association (JAMA).
In OASIS-3, elinzanetant demonstrated a statistically significant mean reduction in the frequency of moderate to severe VMS from baseline to week 12 compared to placebo. The VMS reductions were maintained throughout the study duration. OASIS-3 reinforced the findings from OASIS-1 and -2, reporting a sustained benefit and safety profile over 52 weeks with the most frequently reported treatment emergent adverse events with elinzanetant versus placebo being headache, fatigue and somnolence. Detailed results of the Phase III study OASIS 3 were published in The Journal of the American Medical Association (JAMA) Internal Medicine in September 2025.
In OASIS-4, which investigated elinzanetant in women taking endocrine therapy for treatment or prevention of hormone receptor (HR+) breast cancer, the compound showed a statistically significant reduction in the frequency of moderate to severe VMS from baseline to weeks 4 and 12 compared to placebo. Key secondary endpoints showed statistically significant improvements of sleep disturbances and menopause-related quality of life from baseline to week 12 versus placebo. Additional secondary endpoints showed a reduction in VMS frequency at week 1 and improvements in VMS severity at weeks 4 and 12 versus placebo. The safety profile over 52 weeks observed in the OASIS-4 study was generally consistent with previously conducted studies and published data on elinzanetant in postmenopausal women with fatigue, somnolence and diarrhea being the most frequent treatment emergent adverse events (TEAEs) in the elinzanetant group. Data from OASIS-4 were published in the New England Journal of Medicine (NEJM) in June 2025.
