Cerus Corporation announced that the French regulatory agency for medical products, the Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS) has granted regulatory approval in France for use of plasma treated with the Intercept Blood System, subject to official journal publication. Before the plasma system can be launched broadly in France, reimbursement pricing also needs to be established.
"This approval marks a significant step towards commercializing our plasma system in France," said Claes Glassell, president and chief executive officer, Cerus Corporation. "We are pleased that the AFSSAPS approved the plasma system so quickly."
The Intercept Blood System for plasma is designed to provide increased protection to the blood supply from emerging pathogens, such as West Nile virus and Chikungunya virus, and to offer blood centres a better solution for meeting plasma production needs.
The efficacy and safety of Intercept plasma system was evaluated in transfusions comprising approximately 5,000 units. The plasma system is designed to meet blood centre requirements for efficiency, performance and compatibility with both whole blood and apheresis collections.
Approximately 1.5 million plasma units for transfusion are collected annually in Europe. About 70 per cent of those units undergo pathogen inactivation treatment or quarantine to meet European standards for plasma safety.
Cerus Corporation is a biopharmaceutical company that develops and commercializes novel, proprietary products in the fields of blood safety and immunotherapy to provide safer, more effective medical options to patients in areas of substantial unmet medical needs.