U.S. officials granted full approval to a closely watched Alzheimer’s drug on Thursday, clearing the way for Medicare and other insurance plans to begin covering the treatment for people with the brain-robbing disease.
The Food and Drug Administration endorsed the IV drug, Leqembi, for patients with mild dementia and other symptoms caused by early Alzheimer's disease. It’s the first medicine that’s been convincingly shown to modestly slow Alzheimer’s cognitive decline.
Japanese drugmaker Eisai received conditional approval from the FDA in January based on early results suggesting Leqembi worked by clearing a sticky brain plaque linked to the disease.
The FDA confirmed those results by reviewing data from a larger, 1,800-patient study in which the drug slowed memory and thinking decline by about five months in those who got the treatment, compared to those who got a dummy drug.
“This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease," said FDA's neurology drug director, Teresa Buracchio, in a statement.
Isabel Lawrence reports: [ Ссылка ] --
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