CONCORD, Calif.—Cerus Corporation, a biomedical products company focused in the field of blood transfusion safety, announced today that The Community Blood Center (CBC) of Appleton, Wisconsin has received approval by the U.S. Food and Drug Administration (FDA) on their Biologics License Application (BLA) requesting allowance of interstate distribution of platelets which have been pathogen-reduced with the INTERCEPT Blood System.
The Biologics License Application is a common procedure for blood centers to request permission from FDA to introduce a biologic product into interstate commerce. Until a blood center obtains a BLA, they are restricted to distributing INTERCEPT-treated products to hospitals within the state in which they are produced. While some blood centers may distribute primarily in-state, many U.S. blood centers have extensive interstate distribution.
“CBC Appleton’s BLA approval is another important step in our mission to make INTERCEPT the standard of care for transfused blood components,” said William “Obi” Greenman, Cerus Corporation’s president and chief executive officer. “With the BLA approval, CBC can now ship INTERCEPT-treated platelets across state lines, thereby increasing patient access to safe and effective blood products.”
Community Blood Center provides 100% of the blood given to patients at 17 Wisconsin and Michigan hospitals. CBC operates neighborhood-donor centers in Appleton, Oshkosh, Little Chute, and Woodruff. Last year, volunteer donors gave more than 50,000 blood donations with CBC. Since 1955, CBC has worked with blood donors to provide a steady, reliable blood supply for hospitals. CBC is the fourth blood center to receive BLA approval, and six additional blood centers are awaiting BLA approvals.
The INTERCEPT Blood System is designed to reduce the risk of transfusion-transmitted infections by inactivating a broad range of pathogens such as viruses, bacteria and parasites that may be present in donated blood. The nucleic acid targeting mechanism of action of the INTERCEPT treatment is reportedly designed to inactivate established transfusion threats, such as hepatitis B and C, HIV, West Nile virus and bacteria, as well as emerging pathogens such as chikungunya, malaria and dengue. Cerus currently markets and sells the INTERCEPT Blood System for both platelets and plasma in the United States, Europe, the Commonwealth of Independent States, the Middle East and selected countries in other regions around the world. The INTERCEPT Red Blood Cell system is in clinical development.
“Our BLA approval will enable us to supply INTERCEPT-treated platelets for patient care within Wisconsin and throughout the United States,” commented John Hagins, CBC’s president and chief executive officer. “Through increased availability of pathogen reduced products, we can help our hospitals protect patients from transfusion-transmitted infections, including from bacteria and newly emerging pathogens.”
