Myovant Sciences and Gedeon Richter have gained an approval from the European Commission (EC) for its uterine fibroids treatment Ryeqo, the company announced yesterday.
The EC has cleared Ryeqo (relugolix/estradiol/norethindrone acetate 0.5mg) for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age with no limitation for duration of use.
The approval is based on data from the Phase III LIBERTY programme, consisting of two clinical studies, a one-year extension study and supportive one mineral density data from a randomised withdrawal study.
“Data from the Phase III LIBERTY program, which supported the approval of Ryeqo, showed that Ryeqo improved symptoms most relevant to women living with uterine fibroids, namely heavy menstrual bleeding and pain, while maintaining a well-tolerated safety profile,” said Roberta Venturella, investigator in the LIBERTY programme.
“With this approval, women and doctors finally have a long-term treatment option, which is important for the management of this condition,” she added.
Uterine fibroids present as non-cancerous tumours that develop in or on the muscular walls of the uterus.
Although uterine fibroids are benign tumours, they can cause debilitating symptoms including heavy menstrual bleeding, pain, increased abdominal girth and bloating, urinary frequency or retention, constipation, pregnancy loss and in some cases infertility.
“[The] approval of Ryeqo, the first and only once-daily long-term treatment for women with uterine fibroids in Europe, marks a major milestone in expanding non-invasive treatment options for this common and potentially debilitating disease,” said David Marek, chief executive officer of Myovant Sciences.
“Through our partnership with Gedeon Richter, we look forward to supporting even more women suffering from uterine fibroids,” he added.