• Regulatory NewsRegulatory News

    EMA Consults on Revised Factor VIII Product Guidelines

    The European Medicines Agency (EMA) on Monday issued two draft revised guidelines on plasma-derived and recombinant coagulation factor VIII products that remove requirements for conducting clinical studies in previously untreated patients (PUPs). Background Factor VIII products are used to treat or prevent bleeding in patients with hemophilia A (congenital factor VIII deficiency). The development of inhibitor antibodies is one of the greatest potential complications inv...
  • Regulatory NewsRegulatory News

    EMA Finds No Difference in Inhibitor Risk Between Factor VIII Classes

    The European Medicines Agency (EMA) on Friday said it could find "no clear and consistent" evidence of a difference in the risk of inhibitor development between recombinant and plasma-derived factor VIII medicines. The announcement reconfirms EMA's conclusion from two earlier reviews of factor VIII medicines in 2013 and 2016 . The development of inhibitor antibodies is one of the greatest potential complications involved with treating patients with hemophilia A. When...
  • EMA Calls for Further Research on Personalized Approaches to Treating Hemophilia

    The European Medicines Agency (EMA) has released a new reflection paper on the risks of adverse immune system reactions in hemophilia patients treated with Factor VIII products and how these factors might be mitigated in the future. EMA explains in its 31 July reflection paper that up to 30% of patients with severe hemophilia A experience a buildup of neutralizing antibodies against the treatment, which can cause bleeding. Current therapies tend to focus on treating th...