Cerus Corporation (NASDAQ: CERS) announced today that The Community Blood Center (CBC) of Appleton, Wisconsin received approval by the U.S. Food and Drug Administration (FDA) on their Biologics License Application (BLA) requesting allowance of interstate distribution of platelets that have been pathogen-reduced with the INTERCEPT Blood System.
“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’ 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.”
CBC is the fourth blood center to receive BLA approval. Six additional blood centers are awaiting BLA approvals.
“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.”
The Biologics License Application is a common procedure for blood centers to request permission from FDA to introduce a biologic product into interstate commerce (21 CFR 601.2). 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.