In both editions of Beating the Dementia Monster, we wrote about two prospective monoclonal antibody treatments for Alzheimer's disease. These were aducanumab (now known commercially as Aduhelm) and BAN2401, code name for lecanemab. After my experience auditioning as a trial subject for aducanumab, I was less than fully enthusiastic about it, but I had great hopes for BAN2401.
Well, as events have played out, much of the Alzheimer's world is disappointed in Aduhelm, and lecanemab may struggle as well. On November 29, the New England Journal of Medicine published the peer reviewed results of the clinical trials for the treatment with results that disappointed some. For one thing, two deaths due to brain swelling occurred with patients during the trial that were initially associated with the treatment. Recall that all of the amyloid-eating "mabs" cause brain swelling and micro-hemorrhaging. Biogen's partner, Esai, subsequently released a media statement claiming that the deaths can't be blamed on lecanemab. You can make up your own mind about accepting their claim.
As with Aduhelm, the Alzheimer's Association is all in on lecanemab, and is pressing for prompt approval by the FDA. They made this statement, encouraging the FDA to move ahead. The Alzheimer's Association has perhaps an outsized political presence, and their viewpoint carries a lot of weight.
The researchers who conducted the trial were a bit more circumspect and less optimistic. They concluded, "Lecanemab reduced markers of amyloid in early Alzheimer’s disease and resulted in moderately less decline on measures of cognition and function than placebo at 18 months but was associated with adverse events. Longer trials are warranted to determine the efficacy and safety of lecanemab in early Alzheimer’s disease."
Is this the setup for another drama like the one we had when the FDA approved Aduhelm?
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