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Eisai, Biogen Alzheimer’s drug slows cognitive decline, safety for some comes into focus

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© Reuters. FILE PHOTO: The logo of Eisai Co Ltd is displayed at the company headquarters in Tokyo, Japan, March 8, 2018. REUTERS/Issei Kato/File Photo

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By Deena Beasley

SAN FRANCISCO (Reuters) – An experimental Alzheimer’s drug by Eisai and Biogen (NASDAQ:) has slowed cognitive decline in a closely watched trial but may carry a risk of side effects dangerous for some patients, according to new data presented Tuesday.

The drug lecanemab was associated with a type of brain swelling in 12.6% of test patients, a side effect previously seen with similar drugs. Fourteen percent of the patients had microbleeds in the brain — a symptom associated with two recent deaths of lecanemab users in a follow-up study — and five had a brain hemorrhage.

The companies said in September that the 18-month trial, which involved nearly 1,800 people with early-stage Alzheimer’s disease, found that treatment with lecanemab reduced the rate of decline by 27%. clinical dementia score (CDR-SB) versus placebo. .

Dr Ronald Petersen of the Mayo Clinic in Rochester, Minnesota, said: “All of these amyloid-reducing drugs carry an increased risk of brain bleeding. “I think the primary results, the secondary outcomes, the reduction in amyloid are pretty impressive.”

The trial showed no benefit to CDR-SB for some patients with a genetic risk of developing mind-wasting disease.

About 16% of trial participants had two copies (homozygous) of the APOE4 gene variant known to increase the risk of developing Alzheimer’s disease, 53% had one copy of the gene (heterozygous), and 31% is a carrier of the disease.

“For that small group of patients who are homozygous, when it comes to CDR-SB, we don’t see any indication in favor of lecanemab,” Ivan Cheung, Eisai’s US President, said in an interview. He suggested that could be because homozygous study patients given a placebo had better-than-expected outcomes.

APOE4 carriers showed improvement on test sub-goals, including other measures of cognition and daily function. Overall, lecanemab patients benefited from 23% to 26% compared with placebo for these sub-targets of the trial.

“I believe it’s an important benefit that will justify full approval,” said Dr Paul Aisen, director of the University of Southern California’s Alzheimer’s Therapeutic Research Institute and a co-author of the study. . But of course, we want a bigger benefit.” He said lecanemab is likely to have a greater benefit if used earlier in the disease, “before you have accumulated enough irreversible damage to cause symptoms.”

Detailed data from the study were presented at the Alzheimer’s Disease Clinical Trials meeting in San Francisco and published in the New England Journal of Medicine.

EVIDENCE OF AMYLOID THEORY

Eisai believes the trial results support a longstanding theory that removing the binders of a protein called amyloid beta from the brains of people with early-stage Alzheimer’s can delay progression. of this debilitating disease.

Eisai said that after 18 months, 68 percent of trial participants treated with lecanemab had cleared amyloid.

On Sunday, the journal Science reported the death of a 65-year-old woman being treated with lecanemab. After having a stroke, the woman received a drug called tissue plasminogen activator to remove blood clots and suffered a brain hemorrhage.

Earlier this year, Stat reported that an 87-year-old man in the study, who was taking the blood thinner Eliquis, also suffered a brain hemorrhage and died.

Eisai said they believe the two deaths “cannot be attributed to lecanemab.”

Cheung said Eisai has procedures in place to monitor brain swelling and sees no need to limit which patients may be eligible for treatment with lecanemab.

Dr. Howard Fillit, scientific director of the Alzheimer’s Drug Discovery Foundation (NASDAQ: ) Foundation, said doctors always balance the benefits and risks of therapies. “For now, I would hesitate to give this drug to someone who is taking blood thinners,” he said.

The U.S. Food and Drug Administration is expected to decide on January 6 on whether to approve lecanemab under an “accelerated” review program, which requires proof that a drug Drugs can impact disease-related biomarkers, such as decreased beta amyloid in the brain.

Regardless of that decision, Cheung said Eisai plans to soon apply for FDA standard approval for the drug, based on its recent safety and efficacy data. The company also plans to seek approval in Europe and Japan.



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