NBC News published this article:
The Japanese drugmaker Eisai said Tuesday its experimental drug for Alzheimer’s disease helped slow cognitive decline in patients in the early stages of the illness.
The company said that in a phase 3 clinical trial, the drug, called lecanemab, slowed cognitive decline by 27% after 18 months. The results were announced in a news release and have not yet been peer-reviewed.
The results may offer renewed hope to Alzheimer’s patients after the U.S. drugmaker Biogen’s botched rollout of its drug, Aduhelm, last year. Biogen partnered with Eisai in the commercialization of the new drug, although Eisai led its development and the phase 3 trial.
Outside experts urged caution in interpreting the results, however.
The results are “a first step in the direction of making a significant impact on the disease,” said Dr. Ronald Petersen, a neurologist at the Mayo Clinic in Rochester, Minnesota.
Dr. Alberto Espay, a neurologist at the University of Cincinnati College of Medicine, said that the benefit was "small" and that it fell below the threshold of what would be meaningful to a patient. Still, he said, "patients can view this with cautious optimism."
The results were based on 1,795 patients, who were randomly assigned to receive either the drug or a placebo every two weeks over 18 months. Cognitive decline was measured using a clinical dementia rating scale that focused on six areas: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care.
Brain swelling was seen in 12.5% of those who received the medication, compared to 1.7% in the placebo group, according to Eisai. However, many of those with brain swelling did not experience symptoms and the prevalence of that side effect was lower than what has been seen with other similar experimental drugs, the company said on a call on Tuesday.
Eisai said that it will present the findings at an Alzheimer’s conference in late November and that it plans to submit the trial data to the Food and Drug Administration for approval by March.
The company noted, however, that the FDA has already agreed to consider the drug under the agency's so-called accelerated approval pathway — the same process used to approve Biogen's Aduhelm. Eisai said the agency is expected to make a decision on conditional approval by early January.
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