In an advancement that could change the landscape of endometriosis treatment, pharmaceutical giants Gedeon Richter and Sumitomo Pharma recently received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for RYEQO. The drug, initially approved for the treatment of uterine fibroids, is on track to receive European Commission (EC) approval for the symptomatic treatment of endometriosis.
What This Means for Women
Endometriosis, a disease affecting approximately 10% of women of reproductive age, is characterized by tissue similar to the uterine lining growing outside the uterine cavity. The condition can severely affect general physical, mental, and social well-being. Many women go years before receiving a diagnosis and are often subjected to multiple surgeries to manage pain, only to have symptoms persist or return.
RYEQO offers a new ray of hope. “Once fully approved by the EC, this new therapy could offer a viable treatment option for many women living with endometriosis,” said Dr. Peter Turek, Global Head of Women’s Health at Gedeon Richter.
The Science Behind RYEQO®
The formulation for RYEQO includes relugolix 40 mg, estradiol 1.0 mg, and norethisterone acetate 0.5 mg. Relugolix suppresses the production of estrogen and other hormones in the ovaries, while estradiol may reduce the risk of bone loss. Norethisterone acetate, a progestin, is essential when women with a uterus take estrogen.
Clinical Evidence
The application for RYEQO is supported by robust data. Two 24-week multinational clinical studies, SPIRIT 1 and SPIRIT 2, involved more than 1,200 women with moderate-to-severe endometriosis-related pain. An 80-week open-label extension study also provided valuable information on the drug’s long-term use.
“This recommendation in the EU serves as an important next step towards making this medicine available for more women living with this condition globally,” said Adele Gulfo, Chief Executive Officer, Biopharma Commercial Unit at Sumitomo Pharma America.
Collaboration
Gedeon Richter, headquartered in Budapest, Hungary, specializes in Women’s Healthcare, Central Nervous System, and Cardiovascular areas, boasting the largest R&D unit in Central Eastern Europe. Sumitomo Pharma, based in Japan, focuses on addressing unmet patient needs in multiple therapeutic areas, including women’s health. Both companies aim to make strides in women’s health, fulfilling a critical need for effective treatment options. “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,” Dr. Turek added.
The Road Ahead
The European Commission is expected to make a final decision on RYEQO’s Marketing Authorization Application in the coming months. If approved, this will be applicable to all member states of the European Economic Area.
