Gedeon Richter has been granted a licence by the Medicines and Healthcare Products Regulatory Agency (MHRA) for relugolix combination therapy (Ryeqo), for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
The decision reportedly makes the relugolix combination therapy the first oral gonadotropin-releasing hormone (GnRH) receptor antagonist licensed in Great Britain for these women, says Gedeon Richter.
The ocmpany 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.
“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,” said David Jordan, Medical Director 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 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.”