Mithra Pharmaceutical : Announces promising topline safety results from Donesta® Phase 3 Study in North America
- Phase 3 North American Study topline safety results support overall good safety profile of Donesta®, Mithra's next generation Estetrol (E4)-based product candidate for menopause, as consistently demonstrated in previous E4 studies.
- Topline safety results were demonstrated for the treatment of post-menopausal women aged 40-65 years with moderate to severe vasomotor symptoms with key secondary endpoints achieved, including E4's beneficial effect on cholesterol profile and on bone turnover biomarkers. These highlights will be presented during the webcast dedicated to Mithra's 2022 full year results.
- These results will support the filing with U.S. regulatory agency anticipated by end of H1 2023 for a market authorization in H1 2024, whereas primary safety data are anticipated in H1 2024 for Europe with a market authorization in H1 2025.- Full dataset analysis is still in progress.