FDA Allows Resumption of Lupus Trials With Epratuzumab
Immunomedics, Inc., a biopharmaceutical company focused on developing therapeutic monoclonal antibodies, announced in November that its partner UCB has received notification from the FDA that clinical trials of epratuzumab, its investigational treatment for lupus, may proceed.
Epratuzumab is a monoclonal antibody that has been designed to bind to the CD22 antigen, which is found on B cells. In lupus, B cells can become overactive and produce antibodies that target the body’s own cells and tissues. The binding action of epratuzumab produces several responses within the cell and the body, which seem to cause B-cell depletion and a diminishing of B-cell function. The clinical-hold status of the epratuzumab trials resulted from observations by UCB following a routine audit of the end-stage manufacturing processes, which resulted in UCB’s concerns regarding sterility assurance of the final drug product. The clinical trials have not yet reopened for enrollment.
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