MHRA Approves New Endometriosis Treatment

The Medicines and Healthcare Products Regulatory Agency (MHRA) has granted approval for Gedeon Richter’s Ryeqo, a new treatment for adults suffering from endometriosis symptoms. This makes Ryeqo the first of its kind to be authorized in the UK for this patient demographic. 

Ryeqo is a combination therapy that includes a non-peptide gonadotrophin-releasing hormone receptor antagonist, relugolix (40mg), along with estradiol (1mg) and norethisterone acetate (0.5mg). This therapy is administered as a single once-daily tablet. It is specifically intended for women of reproductive age who have previously undergone medical or surgical treatment for endometriosis.

Endometriosis is a chronic condition affecting around 176 million women globally. It involves the growth of tissue similar to the uterine lining outside the uterus. Women with this condition often suffer from symptoms such as dysmenorrhoea (painful menstrual cramps), heavy menstrual bleeding, and chronic pelvic pain. The disease can also be linked to sub-fertility or infertility.

The MHRA's decision to approve Ryeqo was based on positive outcomes from the late-stage SPIRIT clinical program. In this program, significantly more patients experienced pain relief with Ryeqo compared to a placebo over 24 weeks. In the SPIRIT 1 study, 75% of patients reported relief from dysmenorrhoea with Ryeqo, compared to just 27% in the placebo group. A similar result was observed in the SPIRIT 2 trial, with 75% of patients responding to Ryeqo for dysmenorrhoea versus 30% for placebo.

Additionally, for non-menstrual pelvic pain (NMPP), 59% and 66% of patients in the SPIRIT 1 and SPIRIT 2 studies, respectively, responded positively to Ryeqo. This is in contrast to 40% and 43% of those receiving a placebo. Notably, the reduction in both dysmenorrhoea and NMPP was sustained over a two-year period, as demonstrated by results from a long-term extension study.

David Jordan, the medical director for the UK and Ireland at Gedeon Richter, expressed his enthusiasm about the MHRA’s decision. He highlighted the importance of offering new treatment options for endometriosis, stating, "The MHRA’s decision to license relugolix combination therapy in endometriosis is fantastic news and we are delighted the need for more treatment options has been recognised." Jordan emphasized the company's commitment to providing innovative treatments for women suffering from this painful condition and mentioned that the authorization is a significant step towards redefining care.

Furthermore, Jordan indicated that Gedeon Richter is now working closely with health authorities across the UK to expedite NHS reimbursement for Ryeqo, aiming to make the treatment accessible to those who need it as soon as possible.

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