MYOV - Myovant Sciences gets positive CHMP opinion for RYEQO uterine fibroids treatment

Myovant Sciences (MYOV) announces that the Committee for Medicinal Products for Human Use ((CHMP)) of the EMA has adopted a positive opinion for approval of 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.The European Commission will review the CHMP recommendation, and a final decision on the Marketing Authorization Application is expected to be available in approximately two months.The positive opinion is based on data from the Phase 3 LIBERTY program, which consisted of two replicate, 24-week, multinational clinical studies assessing the safety and efficacy for up to two years of relugolix combination therapy.Shares up marginally during premarket trading.Myovant had announced that the FDA had placed a partial clinical hold on its SERENE study (MVT-601-050), testing its relugolix combination pill, earlier this week.

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Myovant Sciences gets positive CHMP opinion for RYEQO uterine fibroids treatment