emicizumab

Emicizumab, sold under the brand name Hemlibra, is a humanized bispecific monoclonal antibody for the treatment of haemophilia A, developed by Genentech and Chugai (both organizations are subsidiaries of Hoffmann-La Roche). Emicizumab is a bispecific factor IXa- and factor X-directed antibody.

Emicizumab was first approved by the U.S. Food and Drug Administration (FDA) in November 2017 for routine prophylaxis in patients with hemophilia A who have developed factor VIII inhibitors. In October 2018, the FDA expanded approval, under the breakthrough therapy designation, to include all patients with hemophilia A, regardless of inhibitor status. The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication. It is on the World Health Organization's List of Essential Medicines.