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On Tuesday, Bayer AG (OTC:BAYRY) submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for elinzanetant for moderate to severe vasomotor symptoms (VMS, also known as hot flashes) associated with menopause or caused by adjuvant endocrine therapy.
The EMA submission is based on Phase 3 development program OASIS results.
OASIS 1 and 2 data were published in the Journal of the American Medical Association (JAMA) in August.
Detailed results of the Phase 3 study OASIS 3, which provided additional efficacy and safety data over 52 weeks, were presented at the Menopause Society annual meeting in September.
The data showed that elinzanetant met the primary endpoint, demonstrating a statistically significant reduction in the frequency of moderate to severe vasomotor symptoms from baseline to week 12 compared to placebo.
There was no minimum threshold of moderate to severe VMS for inclusion in the study, and at baseline, women had a mean of 6.7 VMS (standard deviation, SD 7.2) in the elinzanetant group and 6.8 in the placebo group (SD 6.2).
After 12 weeks of treatment, VMS was reduced to 1.6 (SD 2.5) in the elinzanetant group and 3.4 (SD 4.2) in the placebo group.
The VMS reductions were maintained throughout the study. In addition, improvements were seen in sleep disturbances and menopause-related quality of life measures with elinzanetant use over 52 weeks.
Last week, the FDA accepted Bayer’s marketing application for elinzanetant seeking approval for moderate-to-severe vasomotor symptoms.
On Monday, Bayer submitted an application to the European Medicines Agency (EMA) for the oral androgen receptor inhibitor (ARi) darolutamide, seeking approval for the use of darolutamide in combination with androgen deprivation therapy in patients with metastatic hormone-sensitive prostate cancer.
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