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Europe Drug Review Approvals

BioMarin Pulls EU Hemophilia Gene Therapy Filing, But Is Not Giving Up

Agios’s MAA For Tibsovo also withdrawn

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Executive Summary

BioMarin plans to resubmit its marketing application for Roctavian to the European Medicines Agency.

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BioMarin’s Roctavian & Argenx’s Efgartigimod Among Eight Hopefuls Awaiting EU Verdict

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.

New EU Filings Include Tibsovo Resubmission, Pegunigalsidase & Daprodustat

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 Secures Fast-Track Review For Hemophilia Gene Therapy In EU

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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