Approval allows interstate shipment of INTERCEPT Platelets
CONCORD, Calif.--(BUSINESS WIRE)--
Cerus Corporation (NASDAQ:CERS) announced today that Rhode Island Blood
Center received approval by the U.S. Food and Drug Administration (FDA)
on their Biologics License Application (BLA) requesting allowance for
interstate distribution of platelets that have been pathogen-reduced
with the INTERCEPT Blood System.
“The BLA approval is a key milestone for Cerus as it improves patient
access to INTERCEPT Platelets. Rhode Island Blood Center now has the
ability to ship INTERCEPT treated blood components across state lines to
hospitals in regions where demand has exceeded supply due to various
factors,” said William “Obi” Greenman, Cerus’ president and chief
executive officer.
Seven additional blood centers have submitted BLAs.
“We can now offer INTERCEPT treated blood components not just in Rhode
Island but throughout Southern New England and with our New York Blood
Center network of affiliated blood centers,” said Lawrence Smith, chief
executive officer of the Rhode Island Blood Center.
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). 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.
ABOUT CERUS
Cerus Corporation is a biomedical products company focused in the field
of blood transfusion safety. 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 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. See http://www.cerus.com
for information about Cerus.
INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus
Corporation.
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Source: Cerus Corporation