Bayer AG, a global pharmaceutical giant, is making strides in the treatment of menopausal symptoms. The company has officially submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for elinzanetant, a novel therapy targeting moderate to severe vasomotor symptoms (VMS), commonly known as hot flashes. This submission marks a significant step towards potentially providing a new treatment option for women experiencing these often debilitating symptoms.
The EMA’s review process will be based on the comprehensive data gathered from the OASIS Phase 3 clinical development program. The results of OASIS 1 and 2 were published in the prestigious Journal of the American Medical Association (JAMA) back in August, showcasing the promising efficacy of elinzanetant. Further validation came from the OASIS 3 trial, whose detailed results were presented at the Menopause Society’s annual meeting in September. This study provided additional evidence of elinzanetant’s effectiveness and safety over a 52-week period.
The clinical data demonstrated that elinzanetant met its primary endpoint, achieving a statistically significant reduction in the frequency of moderate to severe VMS from baseline to week 12 compared to a placebo group. Importantly, the study included women experiencing a wide range of VMS severity. At baseline, women in the elinzanetant group experienced an average of 6.7 VMS per day, while the placebo group averaged 6.8 VMS. After 12 weeks of treatment, the elinzanetant group experienced a reduction to an average of 1.6 VMS per day, compared to 3.4 VMS in the placebo group. This notable improvement in VMS frequency was sustained throughout the duration of the study.
Beyond symptom reduction, elinzanetant also showed improvements in sleep disturbances and quality of life measures associated with menopause over the 52-week study period. These findings suggest that elinzanetant holds the potential to not only alleviate hot flashes but also improve overall well-being for women experiencing menopausal symptoms.
The EMA’s review of Bayer’s application is crucial for the potential availability of elinzanetant to women in Europe. This follows the FDA’s acceptance of Bayer’s marketing application for elinzanetant for the treatment of moderate-to-severe vasomotor symptoms just last week. These developments highlight the company’s dedication to developing novel treatments that address the unmet needs of women experiencing menopause.
It is noteworthy that Bayer has also submitted an application to the EMA for darolutamide, an oral androgen receptor inhibitor (ARi), for use in combination with androgen deprivation therapy in patients with metastatic hormone-sensitive prostate cancer. This submission signifies Bayer’s ongoing commitment to research and development across a range of therapeutic areas.