Cerus Corporation (Nasdaq:CERS) announced today that the American Red Cross has received approval by the U.S. Food and Drug Administration (FDA) for their first biologics license application (BLA) for interstate distribution of platelets that have been pathogen-reduced with INTERCEPT Blood Systems.
“This BLA approval is a key milestone for Cerus and the American Red Cross,” said Vivek Jayaraman, Cerus’ chief commercial officer. “Given the Red Cross’ extensive customer base across the United States, the ability to ship product interstate is critical to reaching hospitals interested in adopting INTERCEPT treated platelets and ensuring patients have access to safer blood components.”
“With 13 Red Cross production sites now producing INTERCEPT platelets, this first BLA approval is an important step toward broader distribution of pathogen reduced platelets,” said Chris Hrouda, president, Biomedical Services for the American Red Cross. “We believe, this approval should help streamline the process for subsequent BLA submissions for our other manufacturing sites. As we receive additional approvals and increase production of INTERCEPT-treated components, we will be able to provide INTERCEPT-treated components to hospitals and patients in regions we are currently unable to reach.”
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 THE AMERICAN RED CROSS
The American Red Cross shelters, feeds and provides emotional support to victims of disasters; supplies about 40 percent of the nation's blood; teaches skills that save lives; provides international humanitarian aid; and supports military members and their families. The Red Cross is a not-for-profit organization that depends on volunteers and the generosity of the American public to perform its mission. For more information, please visit redcross.org or cruzrojaamericana.org, or visit us on Twitter at @RedCross.
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.