BioMarin Rolls Up Sleeves To Prepare For Roctavian’s EU Debut

Positive CHMP Opinion Makes Approval Likely

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.

BioMarin announced a positive CHMP opinion for Roctavian, its gene therapy for hemophilia A • Source: Shutterstock

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