No clear and consistent evidence exists of a difference in risk between plasma-derived and recombinant factor VIII medicines
Following a re-examination procedure, EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed its previous conclusion of May 2017 that there is no clear and consistent evidence of a difference in the incidence of inhibitor development between the two classes of factor VIII medicines: those derived from plasma and those made by recombinant DNA technology.
Factor VIII is needed for blood to clot normally and is lacking in patients with haemophilia A. Factor VIII medicines replace the missing factor VIII and help control and prevent 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 medicines’ effect, so bleeding is no longer controlled.
Due to the different characteristics of individual products within the two classes, the PRAC reaffirmed that the risk of inhibitor development should be evaluated individually for each medicine, regardless of class. The risk for each product will continue to be assessed as more evidence becomes available.
To reflect the evidence currently available, the PRAC confirmed its recommendations that the prescribing information should be updated to include, as appropriate, inhibitor development as a very common side effect in previously untreated patients, and as an uncommon side effect in previously treated patients. The warning on inhibitor development should be amended to highlight that low levels of inhibitors pose less risk of severe bleeding than high levels.
The PRAC’s final recommendation will now be sent to EMA’s Committee for Medicinal Products for Human Use (CHMP) for the adoption of EMA’s opinion. Further details and information for patients and healthcare professionals will be published at that time.
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