Mithra, a company dedicated to Women’s Health, announced that the regulatory submission for E4/DRSP, a combined oral contraceptive containing estetrol (E4) and drospirenone (DRSP), has been submitted to the National Sanitary Surveillance Agency (ANVISA) by Mithra’s commercial partner, Libbs, the Women’s Health leader in Brazil.
Developed by Mithra, the product candidate is composed of 15 mg estetrol, 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.
Graham Dixon, Chief Scientific Officer of Mithra Women’s Health, commented: “The submission to ANVISA completes the global regulatory submission process for Estelle® prior to the first expected approvals in H1 2021. With this submission, Libbs is on-track for potential market authorization in Brazil in H2 2022. To date, Estelle®’s submission has been accepted by the FDA, EMA and Health Canada, where we expect market authorization in H1 2021. We are excited by the upcoming arrival of Estelle® on the market, providing women with a new choice in oral contraception, combining efficacy with a much improved safety profile. Estelle® promises to be a major breakthrough in a space where there hasn’t been any innovation in decades.”