EMA committee recommends approval of Myovant Sciences Orgovyx to treat advanced prostate cancer
Myovant Sciences, a healthcare company focused on redefining care for women and for men, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending the approval of Orgovyx (relugolix, 120 mg) for the treatment of adult patients with advanced hormone-sensitive prostate cancer.
The European Commission (EC) will review the CHMP recommendation, and a final decision on the Marketing Authorization Application is expected to be available in approximately two months. The decision will be applicable to all 27 European Union member states plus Iceland, Norway, and Liechtenstein.
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