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An experimental Alzheimer’s drug developed by Eisai Co Ltd and Biogen Inc significantly slowed cognitive and functional decline in a large study involving patients in the early stages of the disease, the companies said Tuesday.
The injected drug, lecanemab, slowed the progression of the brain-devouring disease by 27 percent compared to a placebo, achieving the primary goal of the study and delivering a clear win for the companies and potentially for patients and their families desperately seeking treatment. an effective treatment.
Eisai said the results of the study involving 1,800 patients prove the long-standing theory that removing sticky deposits of a protein called amyloid beta from the brains of people with early Alzheimer’s can slow the progress of the debilitating disease.
Analysts, such as Salim Syed of Mizuho Securities, have said the results would be considered a “win” if lecanemab slowed the decline by about 25 percent and shares of both companies could jump on the news.
Lecanemab, like the company’s previous drug, Aduhelm, is an antibody designed to remove those amyloid deposits.
Unlike Aduhelm, lecanemab targets forms of amyloid that have not yet clumped together.
An experimental Alzheimer’s drug called lecanemab significantly slowed cognitive and functional decline by 27 percent in a large patient study
Analysts, such as Salim Syed (pictured) at Mizuho Securities, say a 25 percent drop would be a ‘win’
Results from a trial of 1,800 patients proved the theory that removing sticky protein deposits called amyloid beta can slow debilitating disease
Alzheimer’s disease is a progressive, degenerative disease of the brain in which the build-up of abnormal proteins causes nerve cells to die
The so-called amyloid hypothesis has been questioned by some scientists, especially after the controversial 2021 approval of Aduhelm by the U.S. Food and Drug Administration based on its ability to clear plaques rather than evidence that it helped slow cognitive decline. .
The decision came after the FDA’s own panel of outside experts advised against granting approval.
Aduhelm was the first new Alzheimer’s drug to be approved in 20 years after a long list of high-profile industry failures.
Eisai, leader of the 50-50 partnership’s lecanemab program, is seeking FDA approval along the same accelerated track as Aduhelm, and a decision is expected in early January.
But on Tuesday, the Japanese drugmaker said it will use the new efficacy results to submit lecanemab for traditional FDA review.
The company said it will also seek clearance in Japan and Europe during its current fiscal year, which ends March 31.
The phase III trial evaluated the drug’s ability to reduce cognitive and functional decline based on the Clinical Dementia Rating-Sum of Boxes (CDR-SB), a numerical scale used to quantify dementia severity in patients in areas such as memory, orientation, judgment and problem solving, and personal care.
The rate of ARIA-E, a side effect of brain swelling associated with anti-amyloid treatments, was 12.5 percent in the lecanemab group, compared to 1.7 percent in the placebo group.
Although the side effect showed up on imaging, many of these cases were not symptomatic, the companies said.
Symptomatic brain swelling was seen in 2.8 percent of those in the lecanemab group and none in the placebo group, they said.
The drug, lecanemab, is being developed by Biogen and Eisai, the same two pharmaceutical companies behind Aduhelm
Eisai, leader of the 50-50 partnership’s lecanemab program, is seeking FDA approval along the same accelerated track as Aduhelm, with a decision expected in early January.
Symptomatic brain swelling was seen in 2.8 percent of those in the lecanemab group and none in the placebo group
The trial also tracked the rate of brain microbleeds, which occurred at a rate of 17 percent in the lecanemab group and 8.7 percent in the placebo group.
The overall incidence of both conditions was 21.3 percent in the lecanemab group and 9.3 percent in the placebo group, percentages that were within an expected range, the companies said.
Aduhelm’s approval has been a rare bright spot for Alzheimer’s patients, but critics have called for more evidence that amyloid-targeted drugs are worth the cost.
The controversy and reluctance of some payers to cover Aduhelm led Biogen to lower the price of the drug to $28,000 a year, from an initial $56,000.
But Medicare, the US government’s health plan for people over 65, said this year it would only pay for Aduhelm if patients were enrolled in a valid clinical trial, severely curtailing use of the medication.
Since Alzheimer’s disease is a disease of old age, an estimated 85 percent of patients eligible for the drug are covered by the government plan.
According to the Alzheimer’s Association, the number of Americans with Alzheimer’s disease is expected to rise from more than 6 million by 2050 to about 13 million by 2050.
Globally, that figure could rise to 139 million by 2050 without effective treatment, according to Alzheimer’s Disease International.
Other late-stage plaque targeting antibodies for Alzheimer’s patients include gantenerumab from Roche Holding AG and donanemab from Eli Lilly and Co.