New data are sharpening the risk-benefit analysis for lecanemab, an experimental treatment for Alzheimers disease.
In a packed San Francisco conference room with a celebratory atmosphere, upbeat company representatives and scientists yesterday presented detailed clinical trial data on the first Alzheimer’s treatment shown to clearly, albeit modestly, slow the disease’s normal cognitive decline. The antibody therapy has buoyed a field marked by decades of failures. Now, it appears to be on the cusp of being greenlit by the U.S. Food and Drug Administration .
The new data “confirms this treatment can meaningfully change the course of the disease for people in the earliest stages of Alzheimer’s,” the Alzheimer’s Association said in a statement. The antibody also succeeded at thoroughly mopping up amyloid-beta, according to regular brain scans of a subset of participants. A certain level of amyloid buildup in the brain was necessary to qualify for the trial, van Dyck noted, but “at the end of 18 months those in the treated group” were, on average, “below the threshold ... that would get them into the study in the first place.”
“I am not convinced the treatment is ‘disease modifying,’" Matthew Schrag, a neuroscientist and physician at Vanderbilt University, wrote on Twitter. “Almost all of the benefit of treatment occurred in the first year. With disease-modifying treatments, the differences continue to become bigger over time,” he continued.
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