EMA's PRAC concludes review of medicines containing factor VIII

At its May meeting, the Pharmacovigilance Risk Assessment Committee (PRAC), part of the European Medicines Agency, has completed its review of factor VIII medicines to evaluate the risk of developing inhibitors in patients with hemophilia A who have not previously been treated with these medicines.

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

Factor VIII is needed for blood to clot normally and is lacking in patients with hemophilia A. Factor VIII products replace the missing factor VIII and help control bleeding. However the body may develop inhibitors as a reaction to these medicines, particularly in patients starting treatment for the first time. This can block the effect of these medicines, so bleeding is no longer controlled.