Shots:

• The FDA’s BT designation is based on P-III HAVEN 3 study assessing Hemlibra vs no prophylaxis in 152 patients in ratio (2:2:1) with hemophilia A + prior treated with factor VIII therapy aged>12years
• The P-III HAVEN 3 study results: reduction in treated bleeds; superior to prior factor VIII prophylaxis; no thrombotic microangiopathy; no new safety signals observed
• Hemlibra (emicizumab) IV is a bispecific factor IXa- and factor X-directed Ab- with recommended dose qw- q2w- developed by Chugai and co-developed by Roche and Genentech. In 2017- Hemlibra received the US FDA approval to treat hemophilia A with factor VIII inhibitors in adults and children

Ref: Roche | Image: Roche