The U.S. Food and Drug Administration yesterday approved the Intercept Blood System for platelets, the first pathogen reduction system to treat single donor apheresis platelets.
The system is for use by blood establishments that collect and manufacture blood and blood components to prepare pathogen reduced platelets for transfusion to reduce the risk of transfusion-transmitted infections.
On Dec. 16, the FDA also approved the Intercept Blood System for the preparation of plasma to reduce the risk of transfusion-transmitted infections.
The Intercept System for platelets has been shown to reduce the number of a broad range of viruses, bacteria and other pathogens that may contaminate platelets. Examples of some of the pathogens that may be reduced using the Intercept Blood System include HIV, hepatitis B and C viruses, West Nile virus and gram-negative and gram-positive bacteria. The Intercept process also reduces the number of T cells (a type of white blood cell) to a level that lowers the risk of transfusion-associated graft-versus-host disease (TA-GvHD). TA-GvHD is a rare, but often fatal, complication of blood transfusion in which the donor’s T cells attack the recipient’s tissues.
“The Intercept Blood System for platelets represents an important advancement in improving platelet safety, both in reducing the risk of contamination with bacteria and other pathogens and in lowering the risk of transfusion-associated graft-versus-host disease,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research.
The Intercept Blood System for platelets may be used to reduce pathogens in single donor apheresis platelets, a process in which whole blood is drawn from a donor and passed through a cell-separating machine that collects the platelets and then returns the remaining blood components back to the donor. The inactivation of potential pathogens or white blood cell contaminants in the platelets treated using the Intercept Blood System is achieved through a photochemical process involving a controlled exposure to ultraviolet light and amotosalen, a chemical that facilitates the inactivation process. The platelets are then purified to remove the chemical and its byproducts.
While the Intercept System for platelets has been shown to be effective in reducing pathogens, there is no pathogen inactivation process that has been shown to eliminate all pathogens. Certain viruses (e.g. non-enveloped viruses, such as human parvovirus B19) and spores formed by certain bacteria are known to be resistant to the Intercept process.
Platelets prepared using the Intercept Blood System for platelets were evaluated in studies of 844 subjects who received platelets treated by the Intercept system during participation in 10 clinical studies. Post-marketing studies and hemovigilance data from France and Switzerland also supported the use of platelets treated by the Intercept system.
The Intercept Blood System for platelets is marketed by Cerus Corporation, Concord, California.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.