The Food and Drug Administration is expected to decide by Friday whether to grant accelerated approval for Eisai and Biogen's experimental Alzheimer's drug, lecanemab.
Results from a large study earlier this year found that lecanemab slowed the rate of cognitive decline among patients in the early stages of Alzheimer's, boosting its chances for approval, though reports of serious adverse events with trial patients, including brain swelling and bleeding, have raised questions about its safety.
Lecanemab has been one of the first experimental drugs that has had success in slowing the progression of the disease, which has no known cure, offering hope for the over 6 million people in the United States that are living with it and their families.
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