In a sizable study including patients in the early stages of the illness, an experimental Alzheimer’s treatment developed by Eisai Co Ltd and Biogen Inc considerably delayed cognitive and functional deterioration, the firms said on Tuesday.
Lecanemab, an injection, met the primary objective of the research, delayed the progression of the brain-wasting illness by 27% compared to a placebo, providing an apparent victory for the firms and maybe for patients and their families who are in dire need of an effective therapy.
The findings of the 1,800-patient study, according to Eisai, support the long-held belief that clearing amyloid beta protein deposits from the brains of persons with early Alzheimer’s disease may stop the progression of the crippling condition.
Lecanemab’s results would be deemed a “victory” according to analysts, such as Salim Syed of Mizuho Securities, who also predicted that shares of both firms might increase after the announcement.
Lecanemab, like the business’s earlier medication Aduhelm, is an antibody made to get rid of such amyloid buildups.
Lecanemab, as opposed to Aduhelm, targets amyloid formations that have not yet clumped together.
Scientists have questioned the veracity of the so-called amyloid theory, especially in the wake of the FDA’s contentious approval of Aduhelm in 2021 based on plaque-clearing rather than evidence that it slowed cognitive decline.
Following a recommendation against approval from the FDA’s own team of independent experts, the decision was made.
After a lengthy number of well-publicized failures for the business, Aduhelm was the first novel Alzheimer’s medicine licensed in 20 years.
Lecanemab program leader Eisai is requesting FDA clearance under the same expedited process as Aduhelm, with a decision anticipated in early January.
However, the Japanese pharmaceutical company said on Tuesday that it will submit lecanemab for standard FDA assessment using the new efficacy findings.
The business said that during its current fiscal year, which ends on March 31, it would also apply for a license in Japan and Europe.
The Clinical Dementia Rating-Sum of Boxes (CDR-SB), a numerical scale used to quantify the severity of dementia in patients in areas such as memory, orientation, judgment and problem solving, and personal care, was the basis for the Phase III trial’s assessment of the medication’s capacity to reduce cognitive and functional decline.
ARIA-E, a side effect of anti-amyloid therapy that causes brain swelling, was more common in the lecanemab group (12.5%) than in the placebo group (1.7%).
Many of these patients, according to the firms, were asymptomatic despite the adverse effect appearing on imaging.
They reported that no patients in the placebo group and 2.8% of those receiving lecanemab had symptomatic cerebral swelling.
In addition, the experiment monitored the frequency of brain microhemorrhages, which occurred at a rate of 17% in the lecanemab group and 8.7% in the placebo group.
According to the pharmaceutical firms, the overall incidence of both diseases was 21.3 percent in the lecanemab group and 9.3 percent in the placebo group, rates that were within the range of expectations.
The fact that Aduhelm was approved was a rare sign of hope for Alzheimer’s sufferers, but detractors have demanded additional proof that amyloid-targeting medications are worthwhile.
Aduhelm’s price was reduced by Biogen from $56,000 per year to $28,000 as a result of the uproar and certain payers’ unwillingness to cover it.
Aduhelm’s usage was severely restricted when Medicare, the federal health plan for Americans 65 and older, announced this year that it would only cover the drug if patients were involved in an approved research study.
Since Alzheimer’s is an aging-related condition, the government insurance program covers an estimated 85% of individuals who qualify for the medication.
According to the Alzheimer’s Association, among the more than 6 million Americans who have the disease now, there will be around 13 million by the year 2050.
According to Alzheimer’s Disease International, without a cure, that number might increase to 139 million globally by 2050.
Gantenerumab, produced by Roche Holding AG, and donanemab, produced by Eli Lilly and Co., are two further plaque-targeting antibodies for Alzheimer’s patients that are in late-stage research.