PRAC News – May 2016


PRAC concludes on meta-analysis on the risk of inhibitor development in severe haemophilia patients receiving recombinant factor VIII products

The Pharmacovigilance Risk Assessment Committee (PRAC), at its May meeting, adopted a summary report following the review of a meta-analysis of data from three observational studies, aiming to assess the risk of developing inhibitors (antibodies) against individual recombinant factor VIII products in previously untreated patients with severe haemophilia A. Factor VIII is lacking in patients with haemophilia A and is given to these patients either to treat bleeding episodes on demand or regularly as prophylaxis to allow their blood to clot normally; the development of inhibitors can lead to a reduction of the therapeutic action of the medicine.

The PRAC agreed that overall, the currently available evidence does not confirm that Kogenate Bayer/Helixate NexGen is associated with an increased risk of factor VIII inhibitors, compared with other recombinant factor VIII products in previously untreated patients. These conclusions are consistent with the previous conclusions drawn by thePRAC within the review carried out on Kogenate Bayer/Helixate NexGen in 2013.

The PRAC recommended that the marketing-authorisation holders of recombinant factor VIII products should monitor published studies on drug inhibitor development with the aim of keeping the product information up-to-date.

More information on the risk of developing factor VIII inhibitors is available on EMA's website.

More information on the May 2016 PRAC meeting can be found here.