EMA Starts Another Review of Factor VIII-Containing Products

The European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of factor VIII-containing products to evaluate the risk of neutralizing antifactor VIII alloantibodies (inhibitors) developing in patients initiating treatment for hemophilia A, the agency announced today.

The review follows a 2016 study in the New England Journal of Medicine (NEJM) that suggested that inhibitors develop more often in patients receiving factor VIII medicines made by recombinant DNA technology than in those receiving plasma-derived factor VIII products.

The PRAC review will assess data from the NEJM study together with all other relevant data on blood-derived and recombinant factor VIII medicines. The committee will consider the implications of these data for previously untreated patients with hemophilia A, and whether there is a need for "risk minimization measures or other changes to the marketing authorizations of these products," EMA said.

The review covers all medicines containing factor VIII authorized in the European Union.

The review of factor VIII medicines has been initiated at the request of the Paul-Ehrlich-Institut, the German medical regulatory body.

The PRAC recommendations will be sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures–Human, which will adopt a position.

It's not the first time EMA has addressed the risk for inhibitor development with recombinant factor VIII products. As reported by Medscape Medical News, PRAC first studied the risk for factor VIII inhibition in 2013 after a study found that roughly a third of previously untreated children with hemophilia A developed antibodies against two recombinant factor VIII products — Kogenate Bayer and Helixate NexGen.

After reviewing this study and available data at the time, PRAC concluded that the evidence did not point to these two products as having an increased risk of developing factor VIII antibodies compared with other products.

PRAC undertook a second review after two studies published in 2014 again suggested that previously untreated patients with hemophilia A who take Kogenate Bayer and Helixate NexGen may be at greater risk for factor VIII inhibition. This second review also found that these products are not associated with an increased risk of developing counterproductive antibodies in previously untreated patients.


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EMA Starts Another Review of Factor VIII-Containing Products. Medscape. Jul 08, 2016.

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