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.
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Hemlibra receives new approval in Japan intractable disease indication, while positive Phase III results in mild/moderate disease hemophilia A will support a planned EU filing in this setting.
Phase III data for the drug showed strong efficacy among hemophilia A and B patients with inhibitors. The drug’s approval would help drive continued segmentation of the hemophilia market.
In this week's podcast version of Five Must-Know Things: a look a top executive compensation; BioMarin preps for Roctavian’s EU debut; Argenx eyes launch hat-trick for Vyvgart; is a biopharma M&A wave coming; and J&J’s Gorsky offers leadership lessons.