European Commission approves Ryeqo (relugolix 40 mg, estradiol 1.0 mg, and norethisterone acetate 0.5 mg) to treat endometriosis – Gedeon Richter

Gedeon Richter Plc. together with Sumitomo Pharma America, Inc. and Sumitomo Pharma Switzerland, GmbH has announce that the European Commission (‘EC’) 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 15 September 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-to-severe symptoms of uterine fibroids in adult women of reproductive age.