BioMarin Delays Resubmission, But Roctavian’s Rocky Road Winding Down
FDA Request Means Company Expects BLA By End Of September
The company had planned to refile its application at the end of June, though it is gearing up for potential approval and commercialization in Europe that could provide important experience for the US.
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The company plans to start in Germany with an outcomes-based payment model. But while a US FDA nod seems likely, analysts have been more cautious about calling US approval a done deal.
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.
Sanofi and its partner Sobi believe they have the future “Factor VIII of choice” t could also challenge the dominance of Roche’s Hemlibra.