Again Please: BioMarin Seeks Speedy EU Review For Hemophilia Gene Therapy
US BLA Submission For Roctavian Expected Next Year
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.
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The FDA may want longer follow-up data for companies developing treatments for hemophilia A as well as hemophilia B.
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 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.