Emicizumab (Hemlibra)

Mechanism of action

A recombinant, humanized, bispecific monoclonal antibody that bridges activated factor IX and factor X to restore the function of missing activated factor VIII.

Diseases for which it is used

• Acquired factor VIII inhibitor in the setting of inherited factor VIII deficiency

History of changes in FDA indication

• 11/16/2017: Approved "for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors."
• 10/4/2018: Approval expanded "for prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients (ages newborn and older) with hemophilia A (congenital factor VIII deficiency) with or without factor VIII (FVIII) inhibitors. (requirement for inhibitor to be present was removed)

Also known as

• Code name: ACE910
• Generic name: emicizumab-kxwh
• Brand name: Hemlibra