EMA committee completes review of Kogenate Bayer/Helixate NexGen studies

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has completed a review of data examining the risk of inhibitors associated with Kogenate Bayer/Helixate NexGen as compared with other factor VIII products. The PRAC has reaffirmed their conclusion that the currently available data do not confirm that Kogenate Bayer/Helixate NexGen is associated with an increased risk of inhibitors compared with other factor VIII products in previously untreated patients. These conclusions are consistent with the previous reviews held in 2013.

European Medicines Agency – – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 May 2016