BioMarin Resubmits Roctavian Gene Therapy for EU Approval

BioMarin Resubmits Roctavian Gene Therapy for EU Approval

298088

BioMarin Resubmits Roctavian Gene Therapy for EU Approval

BioMarin Pharmaceutical has resubmitted a regulatory application seeking approval in Europe for its experimental gene therapy Roctavian (valoctocogene roxaparvovec) for severe hemophilia A. That resubmission, to the European Medicines Agency (EMA), included one-year follow-up data from BioMarin on the therapy’s safety and effectiveness in treating the rare genetic disorder. The application will be reviewed by the Committee for Medicinal Products for Human Use (CHMP) and the Committee for Advanced Therapies (CAT), two arms of the EMA,…

You must be logged in to read/download the full post.