The Food and Drug Administration granted accelerated approval for Eisai and Biogen's experimental Alzheimer's drug, lecanemab, on Friday, offering a new treatment option for the more than 6.5 million people with Alzheimer's in the United States.
Lecanemab, which targets a type of plaque in the brain made up of the protein beta-amyloid that is believed to cause memory and cognitive problems, showed promising results in slowing the rate of cognitive decline among patients in the early stages of Alzheimer's in a Phase 3 trial, potentially setting it up to garner millions in revenue once it hits the market.
The drug has been one of first to have success in slowing the progression of the disease that has no known cure, but reports of serious adverse events with trial patients, including brain swelling and bleeding, had raised some questions about its safety. The FDA said lecanemab, which will be sold under the name Leqembi, should be started in patients with"mild cognitive impairment or mild dementia stage of disease." The most common side effects are infusion-related reactions, headache, and amyloid-related imaging abnormalities or ARIA, which usually does not have symptoms but could lead to some rare serious and life-threatening events.
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