The Medicines and Healthcare products Regulatory Agency (MHRA) has licensed Gedeon Richter UK’s Ryeqo (relugolix combination therapy) for the treatment of moderate to severe symptoms of uterine fibroids in adults women of reproductive age.
The decision to license Ryeqo is based on results from the Phase III LIBERTY programme, consisting of two 24-week, double-blind, randomised and multinational clinical trials.
Data from the LIBERTY 1 trial showed that 73% of women receiving Ryeqo responded to treatment, while 71% in LIBERTY 2 responded, compared with 19% of women in the placebo groups.
In a statement, Gedeon Richter said the decision makes Ryeqo the first oral gonadotropin-releasing hormone (GnRH) receptor antagonist licensed in Great Britain for these women.
“Over a quarter of women of reproductive age develop uterine fibroids, a chronic condition that can cause debilitating symptoms and significantly impact the quality of life,” said David Jordan, medical director of the UK and Ireland, Gedeon Richter.
“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 that 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,” he added.