Regulatory path for Alzheimer’s drug clouded by brain swelling and bleeding


Alzheimer’s memory loss due to Dementia and brain disease with the abstract medical icon of a human head and neurology research as a 3D illustration. wildpixel/Getty Images

Regulatory path for Alzheimer’s drug clouded by brain swelling and bleeding

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An experimental Alzheimer’s drug made by Eisai and Biogen has shown promising results in slowing the rate of cognitive decline among patients in the early stages of the disease, but new findings from the study are shedding more light on the drug’s risks as U.S. regulators weigh approving it.

The drug, lecanemab, had a moderate effect on reducing cognitive and functional decline among patients that received the drug but had some adverse effects, including swelling and brain bleeding, according to phase 3 trial data published in the New England Journal of Medicine on Tuesday.


“Lecanemab reduced markers of amyloid in early Alzheimer’s disease and resulted in moderately less decline on measures of cognition and function than placebo at 18 months but was associated with adverse events,” the researchers wrote. “Longer trials are warranted to determine the efficacy and safety of lecanemab in early Alzheimer’s disease.”

The long-awaited trial findings come two months after Eisai and Biogen reported in September that the drug reduced cognitive and functional decline by 27% in the test group, compared to those on a placebo treatment, over 18 months in a phase 3 study of nearly 1,800 participants in the early stages of Alzheimer’s disease.

Researchers reported brain bleeding was experienced in 17.3% of those who received lecanemab and 9% who received the placebo and that brain swelling was documented in 12.6% of those who received the drug compared to 1.7% with the placebo.

Safety concerns over lecanemab come as the Food and Drug Administration is expected to make a decision on whether or not to grant the drug approval by Jan. 6, 2023, which is intended to treat the disease by targeting a type of plaque in the brain made up of the protein beta-amyloid, which accumulates in the brains of Alzheimer’s disease patients.

If the FDA decides to approve the drug, it could have an uphill battle for getting covered by Medicare, which is key to making the drug accessible to many patients. Last year, Biogen’s Aduhelm became the first new therapy for the disease in nearly two decades to receive approval but has faced challenges on the market with an initial price tag of $56,000 annually, which Biogen later cut, and Medicare limiting coverage of the drug amid concerns over its effectiveness.


The results of the study were highly anticipated by the Alzheimer’s community as patients and families await new treatments to fight the progressive disease, which has no known cure.

“These peer-reviewed, published results show lecanemab will provide patients more time to participate in daily life and live independently,” the Alzheimer’s Association said in a statement Tuesday. “It could mean many months more of recognizing their spouse, children and grandchildren.”

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