Mithra, a company dedicated to Women’s Health, is very pleased to announce that the European Commission has accepted the registration application for the novel combined oral contraceptive Estelle®. This decision follows the adoption of a positive opinion by the Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency ("EMA") on 26 March 2021 and is valid for all Member States of the European Union.
Developed by Mithra, Estelle® 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.
The product will be marketed in whole Europe by Richter under the brand name Drovelis® and in Belgium and Luxemburg by Ceres Pharma under the brand name Lydisilka®. The commercial launch of Estelle® in Europe will be phased during the second half of the year, starting with Germany, Austria and Poland. Once launched, Estelle® will be the first new estrogen in a COC in the European market in over half a century. Currently, the total European contraceptives market is valued at approximately EUR 2.4 billion annually. As a result of receiving European approval for Estelle®, Gedeon Richter will pay Mithra EUR 15 million in cash.
“After Estelle® approval granted in the US and in Canada, we are very pleased with this third approval given by the European Commission”, said Leon Van Rompay, CEO of Mithra. “It is a great pride for all our teams to offer the result of so many years of research available to women around the world. “