Japan-Specific Approval For Hemlibra In Acquired Hemophilia A
New Data Also In Mild/Moderate Disease
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.
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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.
Sanofi is hoping to have two paradigm-changing hemophilia drugs on the market by 2025 – but one of these, fitusiran, must first prove its safety and efficacy at a lower dose.
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.