BioMarin Secures Fast-Track Review For Hemophilia Gene Therapy In EU
Will It Be Second Time Lucky For Potential New Treatment?
BioMarin plans to file for approval of its investigational hemophilia A gene therapy in the EU in June this year but its US filing is not planned until Q2 2022. It will be the company's second attempt at success in both jurisdictions.
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Novartis is one of the latest companies to fail in its attempt to have a marketing authorization application fast-tracked at the European Medicines Agency. There was better news for BioMarin.
BioMarin is planning to resubmit its EU marketing application for Roctavian soon and, as with the previously pulled application, it wants the regulators to fast-track the new filing.
BioMarin plans to resubmit its marketing application for Roctavian to the European Medicines Agency.