European Medicines Agency Reviews Inhibitor Development Risk in Hemophilia A Treatment

In response to the SIPPET study that was published this spring by the New England Journal of Medicine, the European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has initiated a review of factor VIII-containing products and the risk of inhibitor development for initial hemophilia A treatment.  This is not the first time the that this body has considered the risk of inhibitor development with recombinant factor VIII products; it also did so in 2013 and 2014 in response to three separate studies related to risks associated with recombinant factor VIII products.  Following its review PRAC will make a set of recommendations, after which the Co-ordination Group for Mutual Recognition and Decentralised Procedures-Human will adopt a position.  Source: "EMA Starts Another Review of Factor VIII-Containing Products" via