Europe OK's Myovant's Relugolix Combo Therapy For Uterine Fibroids

The European Commission (EC) has approved Myovant Sciences Ltd's MYOV 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.
The approval is based on safety and efficacy data from the Phase 3 LIBERTY program, which consisted of two replicate, 24-week, multinational clinical studies (LIBERTY 1 and LIBERTY 2), a one-year extension study, and supportive bone mineral density data from a randomized withdrawal study.
Gedeon Richter will commercialize Ryeqo, starting in the 2H of 2021.
Myovant to receive regulatory milestone payment and is eligible to receive tiered royalties on net sales as well as sales milestone payments.
The marketing authorization application for Ryeqo for endometriosis-associated pain is on track for submission in 2021.
Price Action: MYOV shares closed at $19.73 on Monday.
Related content: Benzinga's Full FDA Calendar.