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
Related News:- Roche Presents P-III (HAVEN 6) Study Results of Hemlibra (emicizumab) for Moderate or Mild Haemophilia A at ISTH 2022
