Roche Receives the EC's Approval for Label Expansion Approval of Hemlibra (emicizumab) for Moderate Haemophilia A
- The EC has approved a label expansion of Hemlibra (bispecific factor IXa- and factor X-directed Ab) in patients with a mod. haemophilia A. The approval was based on the results of the P-III trial (HAVEN 6) evaluating the safety, efficacy, PK & PD of Hemlibra
- The results showed effective bleed control & favorable safety profile, 70.8% had mod. haemophilia A without factor VIII inhibitors with no new safety signals, patients experienced no bleeds/no spontaneous bleeds/no joint bleeds were 66.7%/81.9%/88.9%, respectively
- The decision was also based on real-world data while the label expansion will provide an effective & convenient prophylactic treatment option for patients with a mod. haemophilia A with a sev. bleeding phenotype
Ref: Globenewswire | Image: Roche
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