Bayer has applied for marketing authorization from the European Medicines Agency (EMA) for elinzanetant, a drug intended to treat moderate to severe vasomotor symptoms (VMS), commonly known as hot flashes, associated with menopause. This submission follows the acceptance of a new drug application (NDA) by the U.S. Food and Drug Administration (FDA) for the same indication, marking a significant step toward expanding treatment options for menopausal women. Elinzanetant, a dual neurokinin-1 and 3 (NK-1 and 3) receptor antagonist, offers a non-hormonal approach to managing VMS, addressing a critical need for women who cannot or prefer not to use hormone replacement therapy.
Elinzanetant: A Novel Non-Hormonal Option
Traditional treatments for hot flashes often involve hormone therapy, which can carry long-term health risks. Elinzanetant, acquired by Bayer through its 2020 acquisition of KaNDy Therapeutics, presents a non-hormonal alternative. It modulates KNDy neurons in the hypothalamus, which are responsible for regulating body temperature. By acting as a dual NK-1 and NK-3 receptor antagonist, elinzanetant helps to stabilize these neurons, reducing the frequency and severity of hot flashes.
Clinical Efficacy and Safety
The application to the EMA is supported by data from the Phase III OASIS program, which included four studies. Results from OASIS 1 and 2, published in JAMA in August 2024, demonstrated statistically significant reductions in VMS frequency and severity compared to placebo. The OASIS 3 study further supported these findings, providing efficacy and safety data over 52 weeks. These studies enrolled over 1,400 postmenopausal women aged 40 to 65. The ongoing OASIS 4 study is evaluating elinzanetant in women experiencing hot flashes due to endocrine therapy for breast cancer treatment or prevention.
In the OASIS 3 trial, participants had a mean of 6.7 VMS in the elinzanetant group and 6.8 in the placebo group at baseline. After 12 weeks of treatment, VMS was reduced to 1.6 in the elinzanetant group and 3.4 in the placebo group. These reductions were maintained throughout the 52-week study, with improvements also observed in sleep disturbances and menopause-related quality of life.
Market Competition and Future Prospects
If approved, elinzanetant will compete with Astellas' Veozah (fezolinetant), an NK-3 receptor agonist approved in Europe in December 2023. While Veozah has faced challenges in meeting initial financial expectations, analysts predict significant market potential for both treatments. GlobalData forecasts peak revenues of $1.2 billion for elinzanetant by 2030.
Bayer's submission to the EMA includes individuals experiencing hot flashes from adjuvant endocrine therapy, potentially expanding the drug's reach. This strategic move underscores Bayer's commitment to providing personalized care and addressing the diverse needs of women experiencing menopausal symptoms. According to a recent survey, 67% of European women report experiencing VMS during menopause, highlighting the substantial need for effective treatments.
Bayer is also conducting the NIRVANA study (NCT06112756), a Phase II trial exploring the efficacy of elinzanetant on sleep disturbances associated with menopause, further demonstrating the company's dedication to improving the lives of women experiencing menopause.
