Cerus, FDA Reach Agreement on Modular Premarket Approval Application Submission Process for INTERCEPT Plasma

Cerus Corporation

announced today that the U.S. Food and Drug Administration (FDA) has accepted its proposed modular Premarket Approval application (PMA) shell for review of the INTERCEPT Blood System for plasma. A PMA shell is an outline of the application process that defines the structure, content and timing of each module. FDA and the applicant need to agree on a shell prior to initiation of a modular PMA submission. A modular PMA review process is based on submission of a compilation of sections or "modules" at 90-day intervals that together become a complete PMA. Under a modular approach, FDA is able to review each module separately, allowing the applicant to receive timely feedback and potentially resolve deficiencies earlier in the review process than would be expected with a traditional PMA application. Cerus recently announced its intention to pursue a modular PMA submission after dialogue with the FDA indicated that the company could proceed with an application for multiple indications of plasma use, not just the thrombotic thrombocytopenic purpura (TTP) indication for which Cerus received orphan drug designation last year.