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Scientific Publications by FDA Staff

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J Thromb Haemost 2012 Sep;10(9):1961-5

Observations Regarding the Immunogenicity of BDD-rFVIII Derived from a Mechanistic Personalized Medicine Perspective.

Sauna ZE, Ameri A, Kim B, Yanover C, Viel KR, Rajalingam R, Cole SA, Howard TE

Abstract

Aledort et al. recently reported the results of a meta-analysis of prospective clinical trials of the two classes of recombinant Factor VIII (rFVIII) products, B-domain-deleted (BDD) and full-length (FL) [1]. The authors claimed that exposure to BDD-rFVIII was associated with an increased risk of de novo inhibitors. A detailed critique of the meta-analysis conducted in this report was provided by Iorio et al. [2] and the conclusions of Aledort and coworkers remain highly controversial. © 2012 International Society on Thrombosis and Haemostasis.


Category: Journal Article, Letter
PubMed ID: #22734827 DOI: 10.1111/j.1538-7836.2012.04830.x
Includes FDA Authors from Scientific Area(s): Biologics
Entry Created: 2012-06-06 Entry Last Modified: 2012-10-09
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