**The National Institute for Health and Care Excellence (NICE) has recommended Gideon Richter’s Ryeqo (relugolix, estradiol and norethisterone) as the first long-term daily pill for endometriosis.**
NICE has recommended in final draft guidance that the relugolix combination therapy be used on the NHS in England to treat the symptoms of endometriosis in adults of reproductive age who have had medical or surgical treatment for the chronic condition.
The health technology assessment agency’s decision follows an earlier negative recommendation and comes after Gideon provided new evidence on the Ryeqo’s effectiveness and value for money.
Affecting approximately 1.5 million women in the UK, endometriosis occurs when tissue similar to the lining of the uterus grows elsewhere in the body. Patients can experience a range of symptoms, including dysmenorrhoea (painful cramping, usually in the lower abdomen), heavy bleeding and pelvic pain.
Ryeqo is designed to block the specific hormones that contribute to endometriosis while also providing necessary hormone replacement in a single daily tablet. NICE estimates that around 1,000 patients per year could benefit from the therapy.
Helen Knight, director of medicines evaluation at NICE, said Ryeqo “marks a potential step-change in how we manage endometriosis”.
She continued: “Instead of travelling to clinics for injections, there is now a daily tablet that can be taken at home. The treatment can also be stopped and started more easily, which is particularly important for those planning to have children and for managing side effects.”
Among the clinical evidence supporting NICE’s recommendation were 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 SPIRIT 2, 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.
Positive long-term efficacy data from the SPIRIT open-label extension study, which showed that dysmenorrhoea and NMPP reduction was sustained over two years with Ryeqo treatment, also supported the agency’s decision.