Factor VIII drugs Kogenate and Helixate NexGen not linked with an increased risk, says PRAC

The European Medicines Agency’s 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 hemophilia A.

Factor VIII is lacking in patients with hemophilia 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 from Bayer (BAYN: DE) Bayer/Helixate NexGen from CSL Behring, a unit of Australia's CSL Ltd (ASX: CSL), is associated with an increased risk of Factor VIII inhibitors, compared with other recombinant Factor VIII products in previously untreated patients.