MHRA licenses Gedeon Richter’s Ryeqo for symptoms of uterine fibroids  

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The Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a licence for Ryeqo▼ (relugolix combination therapy), for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.

The decision makes the relugolix combination therapy the first oral gonadotropin-releasing hormone (GnRH) receptor antagonist licensed in Great Britain for women.

The MHRA licence is based on outcomes from the Phase 3 LIBERTY programme, which consists of two replicate, 24-week, double-blind, randomised, multinational clinical trials (LIBERTY 1 [n=388] and LIBERTY 2 [n=382]). Pivotal data, which have been published in the New England Journal of Medicine, showed that 73% of women receiving the relugolix combination therapy in LIBERTY 1 and 71% in LIBERTY 2 responded[1] to treatment (primary endpoint), compared with 19% and 15% of women, respectively, in the placebo groups.

Gedeon Richter has initiated discussions with the National Institute of Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC), with final advice for the availability of the relugolix combination therapy expected to be published in 2022.

David Jordan, Medical Director UK and Ireland, Gedeon Richter said: “Over a quarter of women of reproductive age develop uterine fibroids, a chronic condition that can cause debilitating symptoms and significantly impact quality of life. Currently in Great Britain, there are limited therapies available for use, and many women have to decide whether to undergo surgery to alleviate their symptoms. The MHRA’s decision represents a significant milestone. We have now moved a step closer to providing an important new treatment option which has been shown to be effective in treating moderate to severe symptoms of uterine fibroids, such as heavy menstrual bleeding and pain, while offering eligible women a once-daily tablet.”

Tamas Neubauer, Managing Director UK and Ireland, Gedeon Richter said: “The granting of a licence for relugolix combination therapy is fantastic news and we are delighted that the value of this non-invasive treatment has been recognised. We want to redefine care for women living with uterine fibroids and we are engaging with the relevant health authorities throughout Great Britain with a view to securing NHS reimbursement as soon as possible. Our hope is that women suffering from symptoms with this common condition may benefit from greater treatment choice in the future.”

Reference

[1] Volume of menstrual blood loss of less than 80 ml and a reduction of at least 50% from the baseline volume of menstrual blood loss, as measured by the alkaline hematin method over the last 35 days of the treatment period.