REGULATORY UPDATE: FDA Approves Two New Pathogen-Reduced Blood Components

On Nov. 24, the Food and Drug Administration approved Cerus Corporation’s INTERCEPT Blood System for Cryoprecipitation and two products, Pathogen Reduced Cryoprecipitated Fibrinogen Complex (PRCFC) and pathogen reduced plasma, cryoprecipitate reduced, manufactured using the system. PRCFC, granted breakthrough device designation by FDA, received indications including but not limited to the “treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency.” 

PRCFC has a 5-day post-thaw shelf life, may be stored at room temperature and provides “broad spectrum” transfusion-transmitted infection risk reduction. PRCFC may be administered empirically because it does not require a laboratory test result prior to administration. These factors make it possible to have prompt PRCFC availability for “improved treatment of massive hemorrhage,” which serves as the basis for the breakthrough designation by FDA. The indications for use of PRCFC do not include treatment of congenital factor VIII deficiency. There are significant differences between PRCFC and cryoprecipitated antihemophilic factor (cryo AHF) including, PRCFC:

• Is not approved for treatment of congenital factor VIII deficiency.
• Has a shelf life of 5 days versus 6 hours for cryo AHF, 
• May be manufactured from INTERCEPT-processed plasma frozen within 24 hours after collection for whole blood-derived plasma or within 8 hours of apheresis collection. 

Pathogen Reduced Plasma, Cryoprecipitate Reduced is indicated for “transfusion or therapeutic plasma exchange in patients with thrombotic thrombocytopenic purpura. It may be used to provide coagulation factors, except fibrinogen, factor VIII, factor XIII, and von Willebrand factor, for transfusion support of patients with appropriate clinical indications.”