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

Ref: PRNewswire | Image: Roche