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Factor VIII products and inhibitor development: concepts for revision of European regulatory guidelines

Factor VIII products and inhibitor development: concepts for revision of European regulatory... An expert meeting was convened at the European Medicines Agency (EMEA) on 28 February to 2 March 2006, to discuss the standardization and harmonization of requirements for clinical studies on factor VIII inhibitor development in haemophilia A patients. The long‐term objective was to collect comparable clinical data on the immunogenicity of recombinant and plasma‐derived FVIII products in future. Haemophilia treaters, patient organizations, international control authorities and industry were invited by the Committee for Human Medicinal Products (CHMP) and two of its working parties, the Blood Products Working Party (BPWP) and Pharmacovigilance Working Party (PhVWP). This Letter to the Editor summarizes the outcome of the expert meeting. A detailed report on the discussions and consensus reached is published on the EMEA website [ 1 ]. While great progress has been achieved with the pathogen safety of therapeutic products for haemophilia patients, currently the most significant clinical problem is the occurrence of neutralizing antibodies (inhibitors) which jeopardize the success of treatment. Unusual clusters of such inhibitors in previously treated and thus presumably immunotolerant patients may be related to particular products [ 2 ]. Because the size of clinical trials prior to authorization is not sufficient for a definitive exploration of http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Haemophilia Wiley

Factor VIII products and inhibitor development: concepts for revision of European regulatory guidelines

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References (3)

Publisher
Wiley
Copyright
Copyright © 2008 Wiley Subscription Services, Inc., A Wiley Company
ISSN
1351-8216
eISSN
1365-2516
DOI
10.1111/j.1365-2516.2007.01604.x
pmid
18070062
Publisher site
See Article on Publisher Site

Abstract

An expert meeting was convened at the European Medicines Agency (EMEA) on 28 February to 2 March 2006, to discuss the standardization and harmonization of requirements for clinical studies on factor VIII inhibitor development in haemophilia A patients. The long‐term objective was to collect comparable clinical data on the immunogenicity of recombinant and plasma‐derived FVIII products in future. Haemophilia treaters, patient organizations, international control authorities and industry were invited by the Committee for Human Medicinal Products (CHMP) and two of its working parties, the Blood Products Working Party (BPWP) and Pharmacovigilance Working Party (PhVWP). This Letter to the Editor summarizes the outcome of the expert meeting. A detailed report on the discussions and consensus reached is published on the EMEA website [ 1 ]. While great progress has been achieved with the pathogen safety of therapeutic products for haemophilia patients, currently the most significant clinical problem is the occurrence of neutralizing antibodies (inhibitors) which jeopardize the success of treatment. Unusual clusters of such inhibitors in previously treated and thus presumably immunotolerant patients may be related to particular products [ 2 ]. Because the size of clinical trials prior to authorization is not sufficient for a definitive exploration of

Journal

Haemophilia – Wiley

Published: Jan 1, 2008

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