The US Food and Drug Administration on Friday approved a highly anticipated new drug designed to slow cognitive decline in patients in the early stages of Alzheimer's disease.
The FDA approval of the drug, Leqembi, also known as lecanemab, came just days after the agency was harshly criticized in a congressional report for its green-lighting of another Alzheimer's drug, Aduhelm.
Leqembi and Aduhelm, which were both jointly developed by Japan's Eisai and Biogen of the United States,"represent an important advancement in the ongoing fight to effectively treat Alzheimer's disease," the FDA said in a statement. Preliminary data from a trial of Leqembi was released in September and found it slowed cognitive decline in Alzheimer's patients by 27 percent.
And 12.6 percent of those taking the drug experienced brain swelling, compared with just 1.7 percent of those in the placebo group.In Alzheimer's disease, two key proteins, tau and amyloid beta, build up into tangles and plaques, known together as aggregates, which cause brain cells to die and lead to brain shrinkage.
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