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A novel supplemental approach to capturing post-marketing safety information on recombinant factor VIIa in acquired hemophilia: the Acquired Hemophilia Surveillance project

Authors Lentz SR, Tandra A, Gut RZ, Cooper DL

Received 1 October 2013

Accepted for publication 29 October 2013

Published 13 January 2014 Volume 2014:5 Pages 1—3

DOI https://doi.org/10.2147/JBM.S55216

Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 2

Steven R Lentz,1 Anand Tandra,2 Robert Z Gut,3 David L Cooper3

1Division of Hematology, Oncology and Blood and Marrow Transplantation, Department of Internal Medicine, University of Iowa, Iowa City, IA, USA; 2Hematology, Indiana Hemophilia and Thrombosis Center, Indianapolis, IN, USA; 3Clinical, Medical, and Regulatory Affairs, Novo Nordisk, Inc, Princeton, NJ, USA

Acquired hemophilia (AH) is a rare (incidence is 1 per 1.5 million) but often severe bleeding disorder characterized by autoantibodies to coagulation factor VIII (FVIII). It is associated with life-threatening bleeding and ∼20% mortality.1,2 Recombinant factor VIIa (rFVIIa; NovoSeven® RT, Novo Nordisk A/S, Bagsværd, Denmark) received an indication from the US Food and Drug Administration (FDA) in October 2006 for the treatment of bleeding episodes and the prevention of bleeding in surgical interventions or invasive procedures in patients with AH.3

View original paper by Collins and colleagues.

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