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Roche Receives the EC's Approval for Label Expansion Approval of Hemlibra (emicizumab) for Moderate Haemophilia A

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Roche Receives the EC's Approval for Label Expansion Approval of Hemlibra (emicizumab) for Moderate Haemophilia A

Shots:

  • 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

Click here to­ read the full press release 

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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