Roche’s Hemlibra Receives EU’s Approval for Severe Haemophilia A without Factor VIII Inhibitors

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

Click here to read full press release/ article | Ref: Roche | Image: Architura Corporation