Gedeon Richter Contraceptive Approved by the EC

The Hungarian pharmaceutical Gedeon Richter Plc. has announced that the European Commission has granted approval for the marketing authorization of the novel combined oral contraceptive containing 15 mg estetrol and 3 mg drospirenone.

This decision followed a positive opinion from the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) on March 26, 2021 and is applicable for all Member States in the European Union. The product will be marketed in Europe by Richter under the brand name Drovelis®.

“We are delighted with this significant step forward for Drovelis®, as it means more choice for women in need of highly effective and convenient medical therapy for family planning,” the Chairman of Gedeon Richter Plc.Erik Bogsch said. “We remain committed to the development of female healthcare products, which improve quality of life for the female population in all age groups,” he added.

Drovelis® is Richter’s brand name for a novel oral contraceptive product composed of 15 mg estetrol (E4), its unique native estrogen acting selectively in tissues and 3 mg drospirenone. The E4 Freedom studies were open-label single arm trials and they were aimed to assess the safety and efficacy of the product in over 1,550 participants in Europe/Russia and approximately 2,150 participants in the US/Canada, over a period of 13 cycles.