Alzheimer's drug from Eisai and Biogen slows cognitive decline, side-effects in focus
The Hindu
The drug, lecanemab, was associated with a type of brain swelling in 12.6% of trial patients, a side effect previously seen with similar drugs
An experimental Alzheimer's disease drug from Eisai and Biogen slowed cognitive decline in a closely watched trial but may carry a risk of dangerous side effects for certain patients, according to new data presented on Tuesday.
The drug, lecanemab, was associated with a type of brain swelling in 12.6% of trial patients, a side effect previously seen with similar drugs. 14% of patients had microhemorrhages in the brain— a symptom linked to two recent deaths of people receiving lecanemab in a follow-on study, and five patients suffered macrohemorrhages.
The companies said in September that the 18-month trial, which enrolled nearly 1,800 participants with early-stage Alzheimer's, found that treatment with lecanemab reduced the rate of decline on a clinical dementia scale (CDR-SB) by 27% compared to a placebo.
"All of these amyloid-lowering drugs carry a risk for an increased brain hemorrhage," said Dr. Ronald Petersen of the Mayo Clinic in Rochester, Minnesota. "I think the primary outcomes, the secondary outcomes, the amyloid-lowering is pretty impressive."
The Alzheimer's Association said the data confirms the drug "can meaningfully change the course of the disease for people in the earliest stages of Alzheimer’s disease," and called on U.S. regulators to approve the company's application for accelerated approval.
Eisai shares climbed 3% Tokyo Wednesday morning 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's initial findings in late September.
The trial showed no benefit on the CDR-SB measure for some patients with a genetic risk of developing the mind-wasting disease.