Eisai says Alzheimer's drug succeeds in slowing cognitive decline

An Alzheimer's patient rests on a bench after a walk at the Village Landais Alzheimer site in Dax, France, on Sept 24, 2020.Eisai Co Ltd and Biogen Inc on Tuesday said their experimental Alzheimer's drug significantly slowed cognitive and functional decline in a large trial of patients in the early stages of the disease, marking a rare win in a field littered with failed drugs.

Eisai, leader of the 50-50 partnership's lecanemab program, is seeking FDA approval under an accelerated pathway, with a decision expected in early January. On Tuesday the Japanese drugmaker said it will use the new efficacy results to submit lecanemab for traditional FDA review as well. The lecanemab data suggest "a potentially new multi-billion dollar franchise," Jefferies analyst Michael Yee said in a research note.

The so-called amyloid hypothesis has been challenged by some scientists, particularly after the US Food and Drug Administration's controversial approval of Aduhelm in 2021 based on its plaque-clearing ability rather than proof that it helped slow cognitive decline. The decision came after the FDA's own panel of outside experts hadAduhelm was the first new Alzheimer's drug approved in 20 years after a long list of high-profile failures for the industry.

The controversy and reluctance by some payers to cover Aduhelm led Biogen to slash the drug's price to $28,000 per year from an initial $56,000.

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