BioMarin Pulls EU Hemophilia Gene Therapy Filing, But Is Not Giving Up
Agios’s MAA For Tibsovo also withdrawn
BioMarin plans to resubmit its marketing application for Roctavian to the European Medicines Agency.
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Will BioMarin be second time lucky with its hemophilia gene therapy Roctavian in the EU? The European Medicines Agency could soon decide whether the product should be approved.
Servier is trying again with Tibsovo in the EU, while Protalix is using June 2021 data to support its filing for pegunigalsidase, which the US regulator turned down last April.
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.