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FDA News Release

FDA approves first pathogen reduction system to treat plasma

For Immediate Release

December 16, 2014

Release

The U.S. Food and Drug Administration today approved the Intercept Blood System for plasma, the first pathogen reduction system for use by blood establishments in the preparation of plasma in order to reduce the risk of transfusion-transmitted infections (TTI).

“The approval of devices like the Intercept Blood System allows blood establishments to prepare plasma that carries a lower risk of transmitting infectious pathogens through transfusion,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research.

The Intercept Blood System for plasma may be used to reduce pathogens in plasma derived from whole blood and plasma obtained by apheresis, a collection process that separates red blood cells from plasma and then returns the red cells to the donor. Examples of some of the pathogens that may be reduced using the Intercept Blood System include HIV, hepatitis B and C viruses and West Nile virus.

The inactivation of certain potential pathogens in plasma 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 plasma is then purified to remove the chemical and its byproducts.

While the Intercept Blood System for plasma has been shown to be effective in reducing a broad range of viral and bacterial pathogens that may be transmitted through transfusions, there is no pathogen inactivation process that has been shown to eliminate all pathogens. Certain viruses (e.g. human parvovirus B19) and spores formed by certain bacteria are known to be resistant to the Intercept process.

Plasma prepared using the Intercept Blood System for plasma was evaluated in eight clinical studies consisting of a total of 704 patients. The data to support the use of plasma treated by the Intercept Blood System were obtained from clinical trials conducted in various clinical settings. These settings included acquired clotting disorders associated with liver disease and Thrombotic Thrombocytopenic Purpura (TTP), a rare disorder of the blood coagulation system that can cause blood clots to form in small blood vessels throughout the body.

The adverse events experienced by patients who received plasma prepared using the Intercept Blood System for plasma were comparable to those experienced by participants who received plasma that had not been treated with the pathogen reduction device.

The Intercept Blood System for plasma 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 drugs, including vaccines and other biological products for human use, veterinary drugs, 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.

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