MYOV - EC approves Myovant Sciences' Ryeqo marketing application for uterine fibroids

Myovant Sciences (MYOV) announces that the European Commission ((EC)) has approved the marketing authorization application ((MAA)) for Ryeqo (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) 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 safety and efficacy data from the Phase 3 LIBERTY program. In March 2020, Myovant and Gedeon Richter inked license agreement for commercialization of relugolix combination tablet for uterine fibroids and endometriosis in Europe. MAA for endometriosis is expected to be submitted in H2 2021.

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EC approves Myovant Sciences' Ryeqo marketing application for uterine fibroids