Myovant gains EU approval for Ryeqo as treatment for uterine fibroids

The European Commission (EC) has approved the marketing authorization application for Ryeqo (relugolix 40mg, estradiol 1.0mg, and 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 was granted to Myovant Sciences (NYSE: MYOV), which is majority owned by Japan’s Sumitomo Dainippon Pharma (TYO: 4506). The EC decision is valid in all 27 member states of the European Union, as well as Iceland, Norway, and Liechtenstein.

“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 Dr Roberta Venturella, Associate Professor, Magna Græcia University of Catanzaro and investigator in the LIBERTY program, adding: “With this approval, women and doctors finally have a long-term treatment option, which is important for the management of this condition.”