The FDA today announced that it will convene an advisory panel to review the data submitted to support potential approval of donanemab, a monoclonal antibody against the beta amyloid protein that demonstrated efficacy in early Alzheimer’s disease in a recent Phase 3 clinical trial. A positive decision to approve donanemab had been expected before the end of this month. Though data for donanemab’s ability to lower brain amyloid levels are convincing, the FDA had opted not to grant accelera...
