Emicizumab-kxwh: First Global Approval
Related Experiment Video
Updated: Feb 15, 2026

Labeling Stem Cells with Ferumoxytol, an FDA-Approved Iron Oxide Nanoparticle
Published on: November 4, 2011
Lesley J Scott1, Esther S Kim2
1Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.
Abstract:
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.
Related Concept Videos
FDA Approved Drugs: Changes to Approved Drugs
Global Climate Change
Introduction to Global Positioning System
Errors in Global Positioning System
Global Regulatory Systems
Field Application of Global Positioning System

