In a widely-anticipated study, Eisai and Biogen on Tuesday said their Alzheimer's drug slowed cognitive decline among people with early signs of the disease.
"Today's announcement gives patients and their families hope that lecanemab, if approved, can potentially slow the progression of Alzheimer's disease, and provide a clinically meaningful impact on cognition and function," said Michel Vounatsos, Chief Executive Officer at Biogen.
Drug companies have struggled through a long list of failed clinical trials with amyloid-targeting drugs. Biogen's Aduhelm became the first new amyloid-targeting Alzheimer's drug to gain FDA approval last year. It was controversial because it was based on two studies that ended prematurely and yielded mixed results.Brain stimulation could make a 'moderate to large' difference, study shows.
Haruo Naito, Eisai's Chief Executive Officer, said the lecanemab study results"prove the amyloid hypothesis, in which the abnormal accumulation of in the brain is one of the main causes of Alzheimer's disease." If lecanemab secures FDA's accelerated approval in January, Eisai will quickly seek the more conventional, full FDA approval so patients can access the drugs outside of a clinical trial, said Ivan Cheung, Eisai's United States CEO.
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