KFF July 6, 2023
This post was updated on July 6, 2023, to reflect FDA’s approval of Leqembi, additional details from CMS about patient registries, and updated Medicare spending projections.
The FDA has just granted traditional approval to Leqembi (lecanemab), an anti-amyloid monoclonal antibody treatment for Alzheimer’s disease, after granting accelerated approval this past January. Clinical trial results showed that Leqembi, made by Eisai and Biogen, slowed the rate of cognitive decline and reduced amyloid plaques, the protein that accumulates in the brains of people with Alzheimer’s disease – though not without the risk of adverse events. FDA’s approval of a drug that can slow the progression of cognitive decline in patients with Alzheimer’s disease offers long-awaited hope for these patients and their families,...
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