EU Accelerated Assessment Tracker
Novartis Fails To Secure Fast-Track Review For Trabecta
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.
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Amryt Pharmaceuticals is set to appear before the European Medicines Agency to explain why its treatment for patients with epidermolysis bullosa merits EU-wide approval. The drug was recently rejected in the US.
EU marketing authorization applications from Bayer for copanlisib and from Takeda for maribavir will be reviewed under standard timelines at the European Medicines Agency.
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.