CHMP confirms PRAC recommendations on Kogenate Bayer/Helixate NexGen
Benefits continue to outweigh risks in previously untreated patients
The European Medicines Agency’s Committee on Human Medicinal Products (CHMP) has endorsed recent recommendations which concluded that the benefits of Kogenate Bayer and Helixate NexGen, so-called second generation factor VIII products, continue to outweigh their risks in previously untreated patients with the bleeding disorder haemophilia A, but that the product information for these medicines should be amended. The recommendations, issued by the Agency’s Pharmacovigilance Risk Assessment Committee (PRAC), resulted from a review of the medicines which did not confirm a higher risk of developing a type of antibody (factor VIII inhibitors) against these medicines when compared with other factor VIII products. Factor VIII is lacking in patients with haemophilia A and is given to them to allow their blood to clot normally.
The review by the PRAC was triggered by results from a study (the RODIN/PedNet study¹) in previously untreated children with haemophilia A who were given different factor VIII products, as well as preliminary data from the European Haemophilia Safety and Surveillance System (EUHASS). About a third of all the children in the RODIN study developed factor VIII inhibitors against their medicine, which reduces the benefit and makes bleeding more likely. This is a known risk for all factor VIII products but the authors of the study concluded that children given so-called second generation full-length recombinant factor VIII products such as Kogenate Bayer or Helixate NexGen were more likely to develop antibodies than those given a third generation recombinant product. An increase in inhibitor formation was not seen with other recombinant or plasma-derived factor VIII products.
After reviewing current available data on the development of inhibitors in previously untreated patients, the PRAC decided that these data did not support a conclusion that Kogenate Bayer or Helixate NexGen were associated with an increased risk of developing factor VIII inhibitors compared with other products. Although existing measures to minimise all the risks from using the products were considered adequate for both Kogenate Bayer and Helixate NexGen and should be continued, the PRAC recommended that the product information should be updated to reflect results from the RODIN study.
The CHMP considered the PRAC recommendations and agreed by consensus that they should be implemented.
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