Cerus (CERS) Says CBC Submitted BLA to FDA for Interstate Export of INTERCEPT Platelet Components
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Cerus Corporation (Nasdaq: CERS) announced that The Community Blood Center (CBC) of Appleton, Wisconsin has submitted the first Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) requesting allowance for interstate distribution of platelets that have been pathogen-reduced via the INTERCEPT Blood System.
“We look forward to the FDA’s review of our application, and our ability to supply INTERCEPT-treated platelets to hospital customers outside of the state of Wisconsin,” commented John Hagins, CBC’s president and chief executive officer.
“This first BLA submission is an important milestone for Cerus and for CBC as it improves patient access to INTERCEPT components,” said William “Obi” Greenman, Cerus’ president and chief executive officer. “A number of our other customers are also nearing their BLA submissions, moving us one step closer to supplying pathogen-reduced platelets to hospitals in any state in the U.S.”
The Biologics License Application is a common procedure for blood centers to request permission by FDA to introduce a biologic product into interstate commerce (21 CFR 601.2). The FDA has up to 12 months to review each BLA submission. 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.
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