Bayer applies for EU approval of menopause drug elinzanetant
- Bayer has applied for EU approval of its non-hormonal drug elinzanetant to treat menopausal symptoms like hot flashes, positioning itself as a competitor to Astellas' drug, Veozah.
- Elinzanetant works by targeting KNDy neurons responsible for body temperature regulation, offering a promising alternative to hormone replacement therapy, supported by positive results from Phase III OASIS clinical trials.
- With approval applications submitted in multiple regions, Bayer aims to expand treatment options for menopausal women globally, highlighting the potential for significant market presence alongside Veozah, with projected substantial revenues by 2030.
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Bayer, one of the world’s leading pharmaceutical companies, has made a significant move in the treatment of menopausal symptoms by submitting a marketing authorization application to the European Medicines Agency (EMA) for its new drug, elinzanetant. This move is particularly noteworthy as it pits Bayer against Astellas Pharma, which already has a competitor drug, Veozah (fezolinetant), on the market.
What is Elinzanetant?
Elinzanetant is a non-hormonal medication designed to alleviate moderate to severe vasomotor symptoms (VMS) associated with menopause, commonly known as hot flashes. Unlike traditional hormone replacement therapy (HRT), which carries its own set of risks, elinzanetant works by targeting the KNDy neurons in the hypothalamus. These neurons are responsible for body temperature regulation, and their hyperactivation can lead to sudden feelings of intense warmth, known as hot flashes.
How Does Elinzanetant Work?
Elinzanetant acts as a dual neurokinin-1 and 3 (NK-1 and NK-3) receptor antagonist. This mechanism helps in modulating the activity of the KNDy neurons, thereby reducing the frequency and severity of hot flashes. By addressing the root cause of these symptoms directly, elinzanetant offers a promising alternative for women seeking relief from menopausal discomfort without resorting to hormones.
Clinical Trials and Data
Bayer's elinzanetant has undergone extensive clinical trials as part of the Phase III OASIS program. The results from these studies have been highly encouraging. In OASIS 1 and 2, published in the Journal of the American Medical Association (JAMA), the drug demonstrated significant efficacy in reducing hot flashes. The OASIS 3 study, which provided additional efficacy and safety data over a 52-week period, also showed a substantial decrease in the frequency of moderate to severe VMS from baseline to week 12 compared to placebo. These findings support the potential of elinzanetant as a robust treatment option for managing menopausal symptoms.
Competitive Landscape with Veozah
Veozah, developed by Astellas Pharma, is another NK-3 receptor agonist that has already gained approval in Europe. However, despite its regulatory nod, Veozah has not achieved the expected profitability levels. The market demand for Veozah has been lower than anticipated, according to Astellas' FY2023 financial results. This discrepancy highlights a challenge faced by both companies: ensuring that their treatments meet the needs of a diverse population of menopausal women.
Market Potential and Forecasts
GlobalData has forecast that both elinzanetant and Veozah will occupy substantial market shares. The predicted revenues for these treatments by 2030 are $1.2 billion and $1.6 billion respectively. These figures indicate a significant market opportunity for both drugs, which could lead to increased competition and innovation in the treatment of menopausal symptoms.
Personalized Care and Expanded Treatment Choices
Bayer's submission of elinzanetant to the EMA emphasizes the company's commitment to expanding treatment choices for menopausal women. Menopausal symptoms can vary greatly among women in both nature and severity, making personalized care essential. With elinzanetant, healthcare providers will have an additional tool to address the unique needs of each patient, enhancing the overall quality of care.
Regulatory Pathway and International Submissions
Bayer's application to the EMA follows the recent acceptance of a new drug application (NDA) by the US Food and Drug Administration (FDA) for elinzanetant. The company is also pursuing approvals from regulatory bodies in Australia, Canada, Switzerland, and the UK. This multi-regional approach underscores Bayer's strategic commitment to making elinzanetant available globally, thereby maximizing its potential impact on managing menopausal symptoms.
Conclusion
Bayer’s submission of elinzanetant for EU approval marks a significant step in the ongoing quest to provide effective treatments for menopausal symptoms. By challenging Astellas' Veozah with a novel non-hormonal approach, Bayer is poised to offer women a new option for managing hot flashes and improving their overall quality of life. The clinical data supporting elinzanetant’s efficacy, combined with its potential market impact, positions this drug as a major player in the menopause treatment landscape.
