A second study in less than two years suggests a higher risk of inhibitors in previously untreated hemophilia A patients (PUPs) with Kogenate FS and Helixate FS compared to other recombinant FVIII products. The study by Calvez et al of more than 300 boys in France, published in the journal Blood on September 24, 2014, found that the risk of developing inhibitors was close to 60% higher.
In January 2013, the Research of Determinants of Inhibitor Development (RODIN) study group also reported a similarly higher risk of inhibitor development in PUPs treated with this second-generation full-length rFVIII, Kogenate FS/Helixate FS, compared to all other FVIII products. The RODIN study was reviewed by regulators and, in December 2013, the European Medicines Agency’s (EMA) concluded that the benefits of Kogenate FS/Helixate NexGen (Helixate FS in Canada) continue to outweigh their risks in PUPs with hemophilia A.
Following the most recent paper, however, the World Federation of Hemophilia’s Therapeutic Products Safety, Supply and Availability Committee (TPSSAC) issued a statement which said: “Based on the available published data, it may be prudent, where other safe clotting factor concentrates are available, to consider not using Kogenate FS/Helixate NexGen for newly diagnosed PUPs with severe hemophilia A.”
The WFH TPSSAC also stated: “There is no evidence of a higher risk of inhibitors with this product in previously treated patients.”
Click here for WFH's complete statement.
HFNZ will continue to monitor developments in this story. Please check the HFNZ and WFH sites for updates.