According to the US biotechnology company Biogen and the Japanese pharmaceutical company Eisai, the drug “Lecanemab” slowed the cognitive decline in late-stage Alzheimer’s by 27 percent in a clinical study with 1,906 participants. There was no improvement in the group that received a placebo instead of the drug. The drug is a humanized version of the mouse antibody mAb158.
At the end of November, Elsai will present the phase III study. However, the preliminary results already available increase the likelihood that the drug will be approved.
The drug is given intravenously and is designed to clear buildup in the blood vessels caused by the buildup of the protein amyloid made in the brain. Some patients have experienced side effects such as brain swelling, bleeding in the brain, headache, confusion, dizziness, blurred vision, or nausea. Eisai had already applied for accelerated approval based on the results. According to the company, it will continue with an accelerated approval process. The company expects the decision on regular approval by the beginning of January.
Not all experts were convinced
Eisai CEO Ivan Cheung said the study is “the first definitively positive large clinical trial showing that you can actually slow Alzheimer’s disease at this very early symptomatic stage.” The drug was showing benefits just six months after starting use, which was steadily increasing, as reported by the New York Times. The companies want to publish more detailed results of the study in November. Some experts said the results were modest and that patients didn’t notice any difference, especially in the early stages of the disease. On an 18-point scale, the slowdown in cognitive decline would only be a 0.45.
The director of the California Alzheimer’s Disease Center at the University of Southern California, Dr. Lon Schneider believes the effect of the drug is small. However, in his opinion, there are also experts who would see a major effect in the study results. Nevertheless, he assumes that lecanemab “would most likely receive regular marketing authorization based on this one study alone.”
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