MHRA Grants License to Gedeon Richter for Combination Therapy to Treat Uterine Fibroids

MHRA has granted a license to Gedeon Richter for Ryeqo to treat moderate to severe symptoms of uterine fibroids in adult women of reproductive age.

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted a license to Gedeon Richter for Ryeqo (relugolix 40 mg, estradiol 1 mg, and norethisterone acetate 0.5 mg) for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.

MHRA’s decision was based on the outcomes from a Phase III clinical program, the data for which have been published in the New England Journal of Medicine. With this decision, Ryeqo (relugolix combination therapy) becomes the first oral gonadotropin-releasing hormone (GnRH) receptor antagonist to be licensed in Great Britain for the specified patient population.

“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 United Kingdom and Ireland, Gedeon Richter, in an Oct. 26, 2021 press release. “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.”

Gedeon Richter has started discussions with the National Institute of Health and Care Excellence and the Scottish Medicines Consortium about the potential availability of the combination therapy. Results of these discussions are expected to be published in 2022.

“The granting of a license for relugolix combination therapy is fantastic news and we are delighted that the value of this non-invasive treatment has been recognised,” added Tamas Neubauer, managing director UK and Ireland, Gedeon Richter, in the press release. “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.”

Source: Gedeon Richter