Gedeon Richter USA, Inc.

The Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a licence for Gedeon Richter’s Ryeqo for adults with endometriosis symptoms, making it the first in a new class of treatments authorised in the UK for this patient population. Those eligible to receive the combination therapy, which consists of non-peptide gonadotrophin-releasing hormone receptor antagonist relugolix 40mg, estradiol 1mg and norethisterone acetate 0.5mg taken in a single once-daily tablet, will be of reproductive age and have a history of previous medical or surgical treatment for their endometriosis. Affecting approximately 176 million women worldwide, endometriosis is a chronic condition that occurs when tissue similar to the lining of the uterus grows outside of the uterus. Patients can experience a range of symptoms, including dysmenorrhoea (painful cramping, usually in the lower abdomen), heavy bleeding and pelvic pain, and the disease can be associated with sub-fertility or infertility. The MHRA’s decision was supported by positive results from the late-stage SPIRIT programme, in which significantly more patients achieved pain reduction with Ryeqo versus placebo at 24 weeks. In the SPIRIT 1 study, 75% of patients responded to Ryeqo for their dysmenorrhoea compared to 27% in the placebo arm. The same result was seen in the SPIRIT 2 trial, with 75% of dysmenorrhoea responders in the Ryeqo cohort compared to 30% for placebo. Additionally, 59% and 66% of patients responded to Ryeqo for their non-menstrual pelvic pain (NMPP) in SPIRIT 1 and 2, respectively, compared to 40% and 43% of those receiving placebo. Dysmenorrhoea and NMPP reduction was also sustained over two years with Ryeqo treatment, according to results from a long-term extension study. David Jordan, medical director UK and Ireland, Gedeon Richter, said: “The MHRA’s decision to licence relugolix combination therapy in endometriosis is fantastic news and we are delighted the need for more treatment options has been recognised. “We have been working hard to bring a new way of treating the condition to clinicians and women suffering with painful symptoms and we believe this authorisation will be a welcome step for redefining care.” Jordan added that the company is now engaging with the relevant health authorities throughout the UK “with a view to securing NHS reimbursement as soon as possible.”