Category: Approval/Launch Region: Europe · Belgium Company: Roche Diagnostics Belgium Nv

EU approves label expansion of Roche Hemlibra to include people with moderate haemophilia A

EU approves label expansion of Roche Hemlibra to include people with moderate haemophilia A
Roche announced that the European Commission approved the expansion of the Hemlibra (emicizumab) European Union (EU) marketing authorisation. The label will now include the routine prophylaxis of bleeding episodes in people with haemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors, who have moderate disease (FVIII =1% and = 5%) with a severe bleeding phenotype. Haemophilia A affects around 900,000 people worldwide, approximately 14% of whom have a moderate form of the disease.

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