Research & Development
Gedeon Richter and Sumitomo Pharma receive positive European regulatory opinion for RYEQO
18 September 2023 -

Gedeon Richter Plc, a Hungary-based pharmaceutical company, along with Sumitomo Pharma America Inc (SMPA) and Sumitomo Pharma Switzerland GmbH (SMPS), subsidiaries of Japan-based Sumitomo Pharma Group, announced on Friday that they have received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending the 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 earlier medical or surgical treatment for their endometriosis.

The European Commission (EC) is to review the CHMP recommendation and a final decision on the Marketing Authorisation Application is expected to be available in the coming months. The EC's decision is to be applicable to all member states of the European Economic Area.

The product 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.

Dr Peter Turek, global head of Women's Health at Gedeon Richter, said: "Broadening the therapeutic reach of our core innovative products demonstrates our tireless pursuit of becoming a leading pharmaceutical company to address women's health issues. Once fully approved by the EC, this new therapy could offer a viable treatment option for many women living with endometriosis."