FatCool schreef op 27 februari 2020 18:42:EMA Accepts Richter’s Marketing Authorization Application (MAA) for Estelle®, a Novel Combined Oral Contraceptive
Belgium, 27February 2020 – 17:45CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announced that the European Medicines Agency (EMA) has accepted Gedeon Richter’s (hereinafter: “Richter”) regulatory submission for Estelle®, a combined oral contraceptive containing estetrol (E4) and drospirenone.
Developed by Mithra, the product candidate is composed of 15 mg estetrol (E4), a unique native estrogen and 3 mg drospirenone. E4 is produced by the human fetus, passing the maternal blood at relatively high levels during pregnancy. In two phase III clinical studies conducted in 3,725 women, E4/DRSP showed positive top-line results against primary efficacy and safety endpoints and achieved positive secondary endpoints including good bleeding profile, cycle control, and tolerability. According to the relevant license agreement, Richter will commercialize the product in Europe, Russia and other CIS countries.
Graham Dixon, Chief Scientific Officer of Mithra Women’s Health, commented: “The submission to the EMA marks a significant step toward commercialization of Estelle® in Europe. With this submission we are on-track for potential market authorization in H12021. Estelle® promises to provide women with a new choice in oral contraception, combining efficacy with a much improved safety profile. In a space where there hasn’t been any innovation in decades, this will be a major breakthrough.”