Shots:

• The approval is based on P-III HAVEN 3 & HAVEN 4 study assessing Hemlibra in 152 & 48 patients haemophilia A without & with/without factor VIII inhibitors aged > 12yrs.
• HAVEN 3 (NCT02847637) study results: met its 1EPs & 2EPS; @1wk. & 2wks. reduction in treated bleeds (96% & 97%); zero treated bleeds (55.6% & 60%); reduction in joint bleed (95% & 95%); reduction in all bleed (95% & 94%). HAVEN 4 study results: zero treated bleed (56%)
• Hemlibra (emicizumab- SC- qw- q2w- q4w) IXa & X factor directed Ab- co-developed by Chugai- Roche and Genentech and is approved in 60 countries including the US in Nov’17- EU in Feb’18 and Japan in Mar’18 for reduction in bleeding episode

Ref: Roche | Image: Roche