Cerus announced that the US Food and Drug Administration (FDA) has approved the INTERCEPT Blood System for platelets.
The INTERCEPT platelet system is approved for ex vivo preparation of pathogen-reduced apheresis platelet components in order to reduce the risk of transfusion-transmitted infection (TTI), including sepsis, and to potentially reduce the risk of transfusion-associated graft versus host disease (TA-GVHD).
The approval marks the first time that a system to inactivate pathogens in platelet components will be available in the United States.
The FDA approved the INTERCEPT Blood System for plasma on December 16. The INTERCEPT systems for both plasma and platelets use the same illumination device, the same active compound (amotosalen) and very similar production steps.
"The synergy and broad utility of the INTERCEPT Blood System as a single platform for pathogen reduction of both platelet and plasma components has been proven through many years of routine use in Europe, and will now be available to blood centers in the U.S.," said William "Obi" Greenman, Cerus’ president and chief executive officer.
Platelets, plasma and red blood cells do not require functional DNA or RNA for therapeutic efficacy. However, pathogens (bacteria, viruses and parasites) and white blood cells do require replication of these nucleic acids in order to transmit infection.
The INTERCEPT Blood System targets this basic biological difference between the therapeutic components of blood, compared to pathogens and donor white blood cells. The system uses a proprietary molecule that when activated by UVA light, binds to and blocks the replication of DNA and RNA, preventing nucleic acid replication and rendering the pathogen inactive.
The INTERCEPT Blood System for platelets has been approved in Europe since 2002 and is currently used in over 100 blood centers in 20 countries.