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Japanese drugmaker Eisai said on Tuesday (January 10) it had submitted a marketing application to the European health regulator for review of its Alzheimer's drug lecanemab, which was recently granted accelerated approval in the United States. The drug, developed in partnership with Biogen, is an antibody that has been shown to remove sticky deposits of a protein called amyloid beta from the brains of those in the early stages of the mind-wasting disease. Nearly all previous experimental drugs using the same approach have failed. The company's application to the European Medicines Agency is based on results from a late-stage study in which the drug was shown to slow down the rate of cognitive decline in patients with early Alzheimer's by 27 per cent, compared with a placebo. Eisai also reiterated its plans to apply for marketing authorization of the drug in Japan by the end of its business year on March 31.

An experimental Alzheimer's drug developed by Eli Lilly and Co slowed cognitive decline by 35% in a late-stage trial, the company said on Wednesday, providing what experts say is the strongest evidence yet that removing sticky amyloid plaques from the brain benefits patients with the fatal disease. Lilly's drug, donanemab, met all goals of the trial, the company said. It slowed progression of Alzheimer's by 35% compared to a placebo in 1,182 people with early-stage disease whose brains had deposits of two key Alzheimer's proteins, beta amyloid as well as intermediate levels of tau, a protein linked with disease progression and brain cell death. The study also evaluated the drug in 552 patients with high levels of tau and found that when both groups were combined, donanemab slowed progression by 29% based on a commonly used scale of dementia progression known as the Clinical Dementia Rating Scale (CDR-SB). Using that scale, experts said Lilly's findings were roughly on par with Eisai Co Ltd and Biogen Inc's lecanemab, sold under the brand name Leqembi, which reduced cognitive decline by 27% in patients with early Alzheimer's in a study published last year. The results drove Lilly's shares to a record high, up more than 6% at $429.85. Dr. Ronald Petersen, an Alzheimer's researcher at Mayo Clinic, said Lilly's trial is the third to show removing amyloid from the brain slows progression of the disease, which could put to rest some lingering doubts about the benefits of drugs in the class and the amyloid-lowering theory. "It's modest, but I think it's real," he said of the benefit, "and I think it's clinically meaningful." Dr. Erik Musiek, a Washington University neurologist at Barnes-Jewish Hospital, said the efficacy looks as good or better than lecanemab.