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 agreed by consensus to endorse recent recommendations concluding 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. The product information for these medicines will be amended to reflect results from the RODIN study.

The Pharmacovigilance Risk Assessment Committee (PRAC) had recommended this action in December after a review of the available data including the RODIN study.

More information on the CHMP decision can be found here >

The paper on the RODIN study can be found here >

Updated January 2014