Emicizumab-kxwh: First Global Approval.

Emicizumab-kxwh (Hemlibra) is a bispecific humanized monoclonal antibody that restores the function of missing activated FVIII by bridging activated FIX and FX to facilitate effective haemostasis in patients with haemophilia A. Subcutaneous emicizumab-kxwh is approved in the USA for use as routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and paediatric patients with haemophilia A (congenital FVIII deficiency) with FVIII inhibitors. Subcutaneous emicizumab-kxwh is awaiting approval in several countries worldwide, including in the EU and Japan, and is undergoing phase 3 development in haemophilia A without FVIII inhibitors. This article summarizes the milestones in the development of emicizumab-kxwh leading to its first global approval for use as prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with haemophilia A.