Helixate NexGen regulatory update

EMA's Pharmacovigilance Risk Assessment Committee (PRAC) concluded that the benefits of Kogenate Bayer and Helixate NexGen from Bayer outweigh the drugs' risk in previously untreated hemophilia A patients. The PRAC initiated a review following results from the RODIN study evaluating Factor VIII products in 574 treatment-naive children with hemophilia A and preliminary 3-year data from the European hemophilia safety and surveillance system (EUHASS). The authors of RODIN concluded that children given second-generation recombinant Factor VIII ( rFVIII) products, such as Kogenate or Helixate - which contain a form of Factor VIII called octocog alfa - were more likely to develop Factor VIII inhibitors than those given a third-generation recombinant product. The PRAC concluded that available data in treatment-naïve patients did not confirm that Kogenate or Helixate were associated with an increased risk of developing Factor VIII inhibitors. The PRAC did recommend an update of the product information for the 2 drugs with results from RODIN. The PRAC recommendation will be forwarded to CHMP, which will adopt a final opinion at its Dec. 16-19 meeting. ...