Reports of deaths potentially linked to the treatment have cast a shadow on what many hail as a landmark approval.
reported three people who had been enrolled in the lecanemab phase III study and then died during the extended phase of the trial, when patients receiving placebo can ask to be given the drug. They died from complications involving brain bleeding and seizures. According to those reports, researchers think that the patients might have died because of a set of conditions known as amyloid-related imaging abnormalities .
Despite the controversies, Reiman hopes that lecanemab’s success will open the door to more accelerated approvals in the future. He is currently partnering with pharmaceutical company Eli Lilly to test its similar monoclonal antibody, donanemab, in a phase III trial that he says is promising so far. The FDA is expected to decide whether to approve donanemab in the coming weeks.
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