102023 715 PM US Food and Drug Administration Approves BioMarins ROCTAVIAN valoctocogene roxaparvovecrvox the First and Only Gene Thera httpsinvestorsbiomarincom20230629USFoodandDrugAdministrationApprovesBioMarinsROCTAVIANTMvaloctocogeneroxaparvovecrvoxtheF 111Clinical Trials Contact Us Careers US Food and Drug Administration Approves BioMarins ROCTAVIAN valoctocogene roxaparvovecrvox the First and Only Gene Therapy for Adults with Severe Hemophilia A       Jun 29 2023 ROCTAVIAN is a OneTime SingleDose Treatment Available for Adults with Severe Hemophilia A to Control Bleeds ROCTAVIANs Approval was Based on Durability Efficacy and Safety Results from the Largest and Longest Phase 3 Study for a Gene Therapy for Hemophilia Majority of Patients Continued to Respond to ROCTAVIAN Treatment over 3 Years Conference Call and Webcast to be Held at 430 pm Eastern Time on Thursday June 29 2023 SAN RAFAEL Calif June 29 2023 PRNewswire  BioMarin Pharmaceutical Inc Nasdaq BMRN a global biotechnology company dedicated to transforming lives through genetic discovery today announced that the United States Food and Drug Administration FDA approved ROCTAVIAN valoctocogene roxaparvovecrvox gene therapy for the treatment of adults with severe hemophilia A congenital factor VIII FVIII deficiency with FVIII activity upper levels of normal ULN