MYOV - Myovant secures European recommendation for prostate cancer therapy

Commercial-stage pharma company, Myovant Sciences (MYOV -0.7%) announced Friday that an expert panel of the European Medicines Agency (EMA) issued a positive opinion on Orgovyx for its approval in the treatment of adults with advanced hormone-sensitive prostate cancer. The decision by the EMA’s Committee for Medicinal Products for Human use (CHMP) will now undergo the review of the European Commission (EC). The final regulatory action on the Marketing Authorization Application (EMA) is expected in nearly two months. A potential approval will take effect across 27 EU member states, in addition to Iceland, Norway, and Liechtenstein. The positive CHMP opinion is backed by data from the Phase 3 HERO study in which Orgovyx was compared against relugolix in more than 1,000 patients. In Dec. 2020, the U.S. Food and Drug Administration (FDA) approved Orgovyx for adults with advanced prostate cancer. For nine months ending Dec. 31, 2021, Myovant (NYSE:MYOV) recorded $53.5M revenue from

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Myovant secures European recommendation for prostate cancer therapy