Mithra, a company dedicated to Women’s Health, is very pleased to announce that its novel combined oral contraceptive Estelle® is now available in Belgium. The product is marketed in Belgium by Richter under the brand name Drovelis® and by Ceres Pharma under the brand name Lydisilka®.
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, that is now synthesised from a plant source. In two phase III clinical studies conducted in 3,725 women, Estelle® showed positive results for primary efficacy and safety endpoints and achieved positive secondary endpoints including good bleeding profile, cycle control, and tolerability.
Approved by the European Medicines Agency (EMA) in May 2021, Mithra’s product is the first new estrogen in a combined oral contraceptive in over half a century. Richter already launched the product in several European countries, like Germany, Austria, Poland, Hungary, Slovakia and now Belgium. Currently, the total European contraceptives market is valued at approximately EUR 1.6 billion annually (1).
Leon Van Rompay, CEO Mithra Women’s Health, commented: “After the successful launch of Estelle ® in the United States, Canada and several European countries, we are extremely pleased to see the first estetrol-based product launched in our country where the project started and was successfully developed. Our teams are particularly proud to see the result of so many years of research and development now available to patients. Finally, Mithra can provide a real alternative in contraception to all women.”
Professor Jean-Michel Foidart, Permanent Secretary of the Royal Academy of Medicine of Belgium and co-founder of Mithra, added: “We’ve been working on estetrol, a native hormone produced by the human body during pregnancy, for many years to develop and bring a new generation contraceptive pill with a clear benefit/risk profile aiming to improve women’s quality of life. This product promises to be a major breakthrough in a space where there hasn’t been any innovation in decades.”