Roche’s Hemlibra (emicizumab injection) Receives Health Canada Approval for Patients with Hemophilia A Without Factor VIII Inhibitors 

Roche’s Hemlibra (emicizumab injection) Receives Health Canada Approval for Patients with Hemophilia A Without Factor VIII Inhibitors

Shots:

  • The approval is based on HAVEN 3 & 4 studies. The P-III HAVEN 3 study results assessing Hemlibra (qw/q2w) vs episodic FVIII & no prophylaxis in 152 patients with hemophilia A without FVIII inhibitors prior treated with episodic/prophylactic treatment with FVIII, resulted in reduction in treated bleeds (96%/97%); zero treated bleeds (55.6% / 60% vs 0%);  zero treated target joint bleed (69.4%/ 77.1% vs 27.8%)
  • The HAVEN IV study results involves assessing of Hemlibra in 41 patients with hemophilia A with/out FVIII inhibitors, prior treated with episodic/prophylactic treatment with FVIII or bypassing agents/FVIII, resulted in 52.8%, 27.8%, 83.3%, 69.4% & 83.3% experiencing zero bleeds including all treated bleed, all bleed, treated spontaneous bleeds, treated joint bleeds & treated joint bleeds respectively
  • Hemlibra (SC) is mAb targeting IgG4, being co-developed by Chugai & Roche and has received approval in the US, EU for hemophilia A with and without factor VIII inhibitors

Click here to read full press release/ article | Ref: PRNewswire | Image: The Pharma Letter