Europe OK's Myovant's Relugolix Combo Therapy For Uterine Fibroids
- The European Commission (EC) has approved Myovant Sciences Ltd's (NYSE: 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.
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