Subsidiaries of Baxter International Inc and Cerus Corporation announced that the companies reached agreement with the U.S. Food and Drug Administration (FDA) on steps for regulatory approval for their pathogen inactivation system for platelets.
Baxter and Cerus have been in ongoing discussions with the FDA throughout the submission of their modular application for their pathogen inactivation system for platelets. The steps that have been agreed upon include conducting a supplemental platelet transfusion study and performing additional analysis of the U.S. Phase III clinical trial data. The clinical trial will be carried out using the commercial set and will provide additional data to address FDA questions related to platelet performance in the U.S. Phase III clinical trial. This commercial set has previously undergone successful European clinical testing and is now commercially available in Europe.
"We are pleased to have reached this agreement, and with these two additional steps we now have a clear path to complete the regulatory submission process," said Stephen T. Isaacs, president and chief executive officer of Cerus. "Our resolve is strong to make the blood supply as safe as possible and we are committed to moving expeditiously to bring this innovative technology to the marketplace."
The two companies expect to complete the additional steps in the next 15- 18 months with regulatory submission to follow shortly thereafter.
Baxter and Cerus' pathogen inactivation system is being developed to potentially protect patients by reducing the risk of transfusion-transmitted diseases. The system is designed to go a step beyond current blood safety measures, which test for certain infectious diseases, by inactivating a broad spectrum of pathogens, including viruses, bacteria, parasites and potentially harmful donor white blood cells in blood components intended for transfusion. For platelets, the system uses a light-activated compound that is designed to target and inactivate pathogens containing DNA and RNA, such as HIV and hepatitis B and C, and to render them harmless by preventing them from replicating.
In 2002 the companies received regulatory approval in Europe for the technology, known as the Intercept Blood System for platelets. The Intercept Blood System is the only pathogen inactivation system that is approved and available for use in Europe with platelets. Patients undergoing chemotherapy, heart bypass surgery and other procedures that require platelet transfusions are expected to benefit from this technology.
Cerus and Baxter are conducting clinical trials of their pathogen inactivation system for use with plasma and red blood cells for transfusion, making their system the only pathogen inactivation technology currently being developed for use with all primary blood components.