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Inhibitor development in previously untreated patients with severe haemophilia A treated with recombinant factor VIII products

The PRAC has concluded a review of a meta-analysis of data from three observational studies (1-3) assessing the risk of developing antibodies against recombinant factor VIII products in previously untreated patients (PUPs) with severe haemophilia A (factor VIII level < 1%). Inhibitor development is the most serious and challenging complication in the treatment of haemophilia A.

More information on this is included in the hyperlink below:

13 May 2016; EMA/PRAC/332348/2016

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