FDA approves Alzheimer’s drug lecanemab amid safety concerns

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.

My only concern with -mab drugs for AD their lack of uptake in the brain. They’re pretty large for a drug & don’t pass thru BBB very well

Why are studies on on lipid medicines like gemfibrizol, sp, being ignored for new drugs with safety issues? It seems to have promising results blocking ab without any real problems as it's well tolerated and already prescribed thousands of times. I guess it doesn't pay as well...

But profits. Huge.

As a former AD researcher, it appears that these two new treatments offer no advantage over tacrine - approved in 1994 for AD. Its successor, donepazil, also had similar efficacy. Both were approved with large Phase 3 trials.

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