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NextImg:FDA approves Eli Lilly Alzheimer’s drug - Washington Examiner

The Food and Drug Administration announced Tuesday the approval of a new Alzheimer’s drug from Eli Lilly, which has demonstrated moderately slow cognitive and memory decline in patients with the disease.

The drug, donanemab, marketed under the label Kisunla, is a once-monthly monoclonal antibody infusion. The drug works by removing the excessive build-up of amyloid plaques in the brain, which are proteins thought to be the cause of thinking issues associated with Alzheimer’s disease.

“Kisunla demonstrated very meaningful results for people with early symptomatic Alzheimer’s disease, who urgently need effective treatment options,” said Anne White, president of Lilly Neuroscience at the pharmaceutical giant. 

Last month, an FDA advisory panel unanimously voted to recommend the approval of the drug despite possible side effects, including brain swelling and bleeding. 

The drug is a second option for the treatment of early Alzheimer’s, following the FDA approval of Leqembi from Eisai last summer. 

Although the clinical trial results for Kisunla proved similar to those of Leqembi, Kisunla is distinct in that data supports patients being able to discontinue treatment if amyloid plaque levels sufficiently decrease, lowering treatment costs.

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The current market cost of Kisunla per vial is $695.65, with a six month course costing $12,522. An 18 month supply costs $48,696.

Last year, the Centers for Medicare & Medicaid Services said they would pay for Alzheimer’s drugs that are granted full approval from the FDA, but physicians will need to gather data on real-world efficacy.