Critics Of Leqembi Approval See Underlying Issues With FDA Decision

While FDA’s long-awaited full approval of a new drug for patients with early Alzheimer’s disease and mild cognitive impairment is enthusiastically greeted by many patient advocates, providers and health researchers who have doubts about the drug’s safety and efficacy say the decision exemplifies broader problems with FDA’s approval process. The critics raise concerns with the safety profile of the early-stage Alzheimer’s treatment Leqembi (lecanemab), and say the difficulty of measuring cognitive decline means it remains unclear how much the drug...