EC Approves Commercialisation of Richter Preparation

The Hungarian pharmaceutical company Gedeon Richter Plc. - together with Sumitomo Pharma America, Inc. and Sumitomo Pharma Switzerland, GmbH - has announced on the website of the Budapest Stock Exchange that the European Commission has granted approval of a Type II Variation application for RYEQO® (relugolix 40 mg, estradiol 1.0 mg, and norethisterone acetate 0.5 mg) for the symptomatic treatment of endometriosis in women with a history of previous medical or surgical treatment for their endometriosis.

This decision followed a positive opinion from the Committee for Medicinal Products for Human Use (‘CHMP’) of the European Medicines Agency (‘EMA’) on September 15, 2023 and is applicable for all Member States in the European Union.

RYEQO® was initially approved by the EMA in July 2021 for the treatment of moderate-tosevere symptoms of uterine fibroids in adult women of reproductive age.

“We are delighted that this approval has opened the way to offer a viable symptomatic treatment option for many women living with endometriosis,” said Dr. Peter Turek, Global Head of Women's Health at Gedeon Richter. “As we aim to become a leading pharmaceutical company in the field of Women’s Healthcare, a sustained broadening of the therapeutic reach of our core innovative products is of utmost importance for us,” he added.

“Approximately 14 million women in the European Union are living with endometriosis, a chronic condition whose painful symptoms can impact a woman’s ability to engage in certain daily activities. We are pleased that as a result of this decision women in the EU living with endometriosis now have another safe and effective symptomatic treatment option,” Adele Gulfo, Chief Executive Officer, Biopharma Commercial Unit at Sumitomo Pharma America, highlighted.