Berlin, Germany – September 19, 2025 — Bayer announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of elinzanetant for the treatment of moderate to severe vasomotor symptoms (VMS)—commonly known as hot flashes—associated with menopause or caused by adjuvant endocrine therapy (AET) in breast cancer. The European Commission is expected to issue a final decision within the coming months. If approved, elinzanetant would become the first dual neurokinin (NK-1 and NK-3 receptor) antagonist authorized in the European Union for these indications.
Science Significance
Elinzanetant is a once-daily, oral first-in-class dual neurokinin (NK) receptor antagonist designed to target both NK-1 and NK-3 pathways involved in thermoregulation. Menopause and endocrine therapies lower estrogen levels, leading to hyperactivation of KNDy neurons—a network of hypothalamic neurons that regulate body temperature—triggering hot flashes and sleep disturbances. By simultaneously inhibiting NK-1 and NK-3 receptors, elinzanetant addresses both the central mechanism of vasomotor symptoms and the peripheral cooling response, offering a non-hormonal alternative to estrogen-based therapies. This dual mechanism sets a new scientific benchmark in women’s health and potentially expands treatment to patients for whom hormone therapy is contraindicated.
Regulatory Significance
The CHMP recommendation follows a robust Phase III clinical development program (OASIS 1–4) evaluating efficacy and safety across diverse patient populations. Elinzanetant met all primary and key secondary endpoints in reducing the frequency and severity of moderate to severe VMS, with significant improvements in sleep quality and menopause-related quality of life. Data were published in JAMA (OASIS-1/2, OASIS-3) and NEJM (OASIS-4), demonstrating sustained benefits and a favorable safety profile over 52 weeks. This positive CHMP opinion is a critical step toward European Commission marketing authorization, which could make elinzanetant the first approved treatment for VMS caused by breast cancer endocrine therapy—a population with no approved options.
Business Significance
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For Bayer, the CHMP opinion represents a strategic milestone in women’s health, reinforcing its leadership in menopause management and oncology supportive care. Elinzanetant is already marketed as Lynkuet™ in Australia, Canada, the UK, and Switzerland for menopause-related VMS, and global filings are underway, including in the United States. Approval in the EU will unlock access to one of the world’s largest menopause and breast cancer markets, estimated to reach billions in annual sales. Bayer’s established women’s health portfolio and global infrastructure provide a strong launch platform to accelerate adoption and expand access to millions of women seeking non-hormonal treatments.
Patients’ Significance
Vasomotor symptoms affect up to 80% of women during menopause, with 67% of European women reporting hot flashes and related disturbances. Symptoms can persist for 10 years or more, impairing quality of life, sleep, and work productivity. For women undergoing endocrine therapy for breast cancer, VMS is even more prevalent—impacting up to 95% of patients—and often forces treatment discontinuation due to intolerable side effects. Elinzanetant offers a much-needed, non-hormonal therapeutic option for both natural and therapy-induced menopause, addressing a major unmet need and supporting better adherence to life-saving breast cancer treatments.
Policy Significance
The CHMP recommendation reflects the EMA’s commitment to advancing innovative, evidence-based therapies in women’s health, particularly where no approved options exist. Approval would reinforce the EU’s broader health policy goals to improve quality of life for aging populations and reduce the societal and economic burden of untreated menopause symptoms, which affect workforce productivity and healthcare utilization. Elinzanetant’s development sets a regulatory precedent for dual-receptor neurokinin antagonists, potentially opening the door for similar non-hormonal interventions in other endocrine-related disorders.
Transaction Highlights
The CHMP’s positive opinion is based on data from the OASIS Phase III program, comprising four multinational, randomized, placebo-controlled trials enrolling over 1,800 women across more than 25 countries. In OASIS-1 and OASIS-2, elinzanetant significantly reduced the mean frequency and severity of moderate to severe VMS compared to placebo at weeks 4 and 12, with efficacy sustained through 26 weeks and over 80% of participants achieving at least a 50% reduction in symptom frequency by week 26. OASIS-3 confirmed durable efficacy over 52 weeks, while OASIS-4 demonstrated significant reductions in VMS frequency and severity in women receiving endocrine therapy for hormone receptor–positive breast cancer—a first for this patient population. The most common treatment-emergent adverse events were headache, fatigue, somnolence, and diarrhea, consistent with prior studies and generally manageable. With CHMP endorsement, Bayer anticipates European Commission approval within months, paving the way for rapid commercial rollout and continued submissions in other key global markets.
Source: Bayer Press Release
