Cerus Reports Positive Topline Results From Phase 3 RedeS Trial
Cerus Corporation announced positive topline results from the Phase 3 RedeS trial (NCT03037164) evaluating the INTERCEPT Blood System for Red Blood Cells, which successfully met its primary efficacy endpoint by demonstrating non-inferiority compared to conventional RBCs in adjusted hemoglobin increment. Despite these findings, the system remains investigational and lacks FDA approval in the United States, with these results neither ensuring regulatory approval nor predicting its timeline.
Cerus Corporation announced positive topline results from the Phase 3 RedeS trial, identified as NCT03037164, evaluating the INTERCEPT Blood System for Red Blood Cells.
The trial met its primary efficacy endpoint, demonstrating non-inferiority of INTERCEPT RBCs compared with conventional RBCs. Non-inferiority was measured by adjusted hemoglobin increment, which is commonly used to assess the effectiveness of red blood cell transfusions.
The INTERCEPT Blood System for Red Blood Cells remains investigational in the United States and has not been approved by the FDA. The topline results do not establish regulatory approval or indicate the timing of any potential approval.
This article may include AI-generated content that is human-reviewed, which is for reference and general information purposes only and does not constitute investment advice.
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