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Emicizumab-kxwh: First Global Approval

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posted on 11.04.2018 by Lesley J Scott, Esther S Kim
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Funding: The preparation of this review was not supported by any external funding.

Conflicts of interest: Lesley Scott and Esther Kim are salaried employee of Adis/Springer, are responsible for the article content and declare no relevant conflicts of interest.

Additional information about this Adis Drug Review can be found at here.

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. Access to the full article can be found here.

© Springer International Publishing AG, part of Springer Nature 2018

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