SAN FRANSICO
\nAn experimental Alzheimer\u2019s drug from Eisai (4523.T) and Biogen (BIIB.O) slowed cognitive decline in a closely watched trial but may carry a risk of serious side effects for certain patients, according to detailed data presented on Tuesday.
\nThe drug, lecanemab, was associated with a dangerous type of brain swelling in nearly 13% of patients in the trial that spanned 18 months and enrolled nearly 1,800 participants with early-stage Alzheimer\u2019s.
\nSome patients also experienced bleeding in the brain, with five suffering macrohemorrhages and 14% suffering microhemorrhages – a symptom linked to two deaths of people receiving the drug in a follow-on study.
\nThe companies said in September that lecanemab – an antibody designed to remove sticky deposits of a protein called amyloid beta – reduced the rate of cognitive decline on a clinical dementia scale (CDR-SB) by 27% compared to a placebo.
\n\u201cAll of these amyloid-lowering drugs carry a risk for increased brain hemorrhage,\u201d said Dr. Ronald Petersen of the Mayo Clinic in Rochester, Minnesota. \u201cI think the primary outcomes, the secondary outcomes, the amyloid-lowering is pretty impressive.\u201d
\nThe Alzheimer\u2019s Association said the data confirms the drug \u201ccan meaningfully change the course of the disease,\u201d and called on U.S. regulators to approve the company\u2019s application for accelerated approval.
\nEisai shares climbed 3.6% in Tokyo afternoon trade while Biogen shares were 0.9% higher in after-hours trade. They have jumped some 60% and 47% respectively since the announcement of the trial\u2019s initial findings in late September.
\nThe full data showed that some patients with a genetic risk of developing the mind-wasting disease did not benefit from lecanemab based on the CDR-SB measure.
\nThey did, however, show improvement for the trial\u2019s secondary goals, including other measures of cognition and daily function. Overall, lecanemab patients benefited by 23% to 37% compared with a placebo on these secondary trial goals
\n\u201cI believe it\u2019s an important benefit that will justify full approval. But of course, we want a bigger benefit,\u201d said Dr. Paul Aisen, director of the University of Southern California Alzheimer\u2019s Therapeutic Research Institute and a co-author of the study published in the New England Journal of Medicine.
\nHe said lecanemab is likely to provide greater benefit if given earlier in the disease, \u201cbefore you\u2019ve accumulated enough irreversible damage to be causing symptoms.\u201d
\nDetailed data from the study were presented at the Clinical Trials on Alzheimer\u2019s Disease meeting in San Francisco.
\nEisai believes the trial results prove a longstanding theory that removing amyloid beta from the brains of people with early Alzheimer\u2019s can delay advance of the disease.
\nAt 18 months, 68% of trial participants treated with lecanemab had amyloid clearance, Eisai said. The drug also lowered levels of tau, a different protein that forms toxic tangles inside brain cells.
\nThe two deaths from brain hemorrhages that were reported in the follow-on study were a 65-year-old woman who received a type of medicine known as tissue plasminogen activator to clear blood clots after suffering a stroke and an 87-year-old who was on the blood thinner Eliquis.
\nEisai said it believes the deaths \u201ccannot be attributed to lecanemab.\u201d
\nThe company has protocols in place for monitoring brain swelling and sees no need for restrictions on which patients might be eligible for lecanemab, Ivan Cheung, Eisai\u2019s U.S. chairman, told Reuters in an interview.
\nDr. Howard Fillit, chief science officer at the Alzheimer\u2019s Drug Discovery Foundation, said doctors always balance the benefits and risks of therapies. \u201cCurrently, I would hesitate to give this drug to someone on blood thinners,\u201d he said.
\nThe U.S. Food and Drug Administration is slated to decide by Jan. 6 whether to approve lecanemab under its \u201caccelerated\u201d review program, which requires proof that a drug can impact a biomarker associated with a disease, such as reduction of amyloid beta in the brain.
\nRegardless of that decision, Cheung said Eisai plans to soon file for standard FDA approval of the drug and will also seek approval in Europe and Japan.<\/p>\n","protected":false},"excerpt":{"rendered":"
SAN FRANSICO An experimental Alzheimer\u2019s drug from Eisai (4523.T) and Biogen (BIIB.O) slowed cognitive decline in a closely watched trial but may carry a risk of serious side effects for certain patients, according to detailed data presented on Tuesday. The drug, lecanemab, was associated with a dangerous type of brain swelling in nearly 13% of […]<\/p>\n","protected":false},"author":2,"featured_media":298544,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[6],"tags":[],"class_list":{"0":"post-298523","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-world"},"yoast_head":"\n