A full autopsy and detailed examination of the brain of a 79-year-old Florida woman who died after receiving lecanemab, an experimental Alzheimer’s therapy, in a pivotal clinical trial has deepened some researchers’ concerns that it poses serious risks for patients who share the woman’s hard-to-diagnose, preexisting condition.
The case report and the experts’ recommendations are likely to be hot topics at an FDA advisory panel meeting on the drug, which the agency this week said would be on 9 June. The panel will assess the drug’s pros and cons before FDA makes its final decision on full approval, likely in July. But the drug, now marketed as Leqembi by its maker Eisai Co., has also been linked to several deaths and brain injuries, as well as to a reduction in brain volume, during its trials or their extensions. The case report, currently under review at a journal, expands on an earlier
Besides weakening blood vessel walls, lecanemab and other antiamyloid antibodies may pose another hazard to people with CAA, Harmsen, Schrag, and their colleagues say. As the antibodies remove clumps of amyloid from brain tissue, the agglomerations may clog blood vessels and lead to “an inflammatory cascade” that increases the risk of life-threatening swelling and bleeding.
The authors of the case report say that’s not enough. “This case should prompt a careful evaluation of the safety of lecanemab treatment and a refinement of the approach to pre-screening potential recipients of lecanemab for [CAA],” they conclude. The group wrote that Alzheimer’s patients with probable CAA and related brain inflammation, as indicated by brain imaging, should not receive lecanemab. Villain calls that proposal too weak. He and colleagues wrote in anof recommendations—for the use of antiamyloid antibodies in France—that any Alzheimer’s patients with probable CAA, even those without evidence of brain inflammation, should not receive lecanemab.
This is important research. Lecanemab is a great second step. I'm watching ProMISinc and their PMN310 closely. Impressive data at AD/PD 2023 showing higher selectivity and potentially lower ARIA-E risk due to less off-target binding $PMN
Is the drug as risky as… oh I don’t know…. Having Alzheimer’s?
If I had alzheimers, I would probably want to take any risk to fight it, it's a horrible disease. Hopefully the drug is still promising.
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