OBSV - ObsEva on track for European approval of uterine fibroids therapy

ObsEva SA (NASDAQ:OBSV) announced that an expert panel of the European Medicines Agency (EMA) endorsed its oral GnRH antagonist linzagolix, recommending its approval for adult women with moderate to severe symptoms of uterine fibroids (UF). The positive opinion adopted by the EMA’s Committee for Medicinal Products for Human Use (CHMP) was based on the data from two Phase 3 PRIMROSE trials for linzagolix, which were part of the company’s Marketing Authorization Application (MAA) for the therapy. A final decision from the European Commission (EC) on its marketing authorization is expected in two months (Q1 2022), ObsEva (OBSV) said. In November, the company announced that the FDA accepted its marketing application for linzagolix as a treatment for menstrual bleeding linked to uterine fibroids in premenopausal women. The U.S. regulator is expected to complete its review by September 2022.

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ObsEva on track for European approval of uterine fibroids therapy