Gedeon Richter and Sumitomo Pharma have been granted approval for Ryeqo (relugolix 40 mg, estradiol 1.0 mg, and norethisterone acetate 0.5 mg) from the European Commission (EC) for the symptomatic treatment of endometriosis in women.
The approved Type II Variation application pertains to the drug’s use in women who have a history of prior medical or surgical treatment for their endometriosis.
The application is backed by two 24-week, multinational clinical trials, namely SPIRIT 1 and SPIRIT 2. The trials involved over 1,200 women experiencing moderate-to-severe pain linked to endometriosis.
Additionally, there is an 80-week open-label extension study designed to evaluate the extended use of Ryeqo.
The EC’s decision comes in the wake of a favourable assessment based on the same findings by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in September 2023. The approval applies to all European Union (EU) member states.
Ryeqo received its initial approval from the EMA in July 2021 for addressing moderate-to-severe symptoms of uterine fibroids in adult women of reproductive age.
Gedeon Richter women’s health global head Peter Turek said: “We are delighted that this approval has opened the way to offer a viable symptomatic treatment option for many women living with endometriosis.
“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.”
Ryeqo comprises relugolix, which lowers the production of estrogen and other hormones by the ovaries and an estrogen called estradiol to potentially minimise the risk of bone loss. It also contains a progestin called norethisterone acetate, which is essential when estrogen is taken by women with a uterus.
The drug was developed by Myovant Sciences, which was acquired earlier this year in a deal worth $1.7bn by Sumitomo Pharma’s fully-owned subsidiary Sumitovant Biopharma.
In 2020, Myovant Sciences signed an exclusive license agreement with the Hungary-based Gedeon Richter to commercialise relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg for uterine fibroids and endometriosis in Europe and other countries.
