Lilly had expected the Food and Drug Administration to decide on donanemab's approval by the end of the month. But the drugmaker said Friday that the agency now…
Eli Lilly Alzheimer’s drugto decide on donanemab's approval by the end of the month. But the drugmaker said Friday that the agency now wants more information about its safety and effectiveness.The FDA often asks committees to review drugs that are first in their class of treatments. Donanemab, if approved, would follow Eisai’s Leqembi, which was approved last year, and Biogen’s Aduhelm.Eli Lilly and Co.
In the study, patients were taken off the drug once their brain plaque reached low levels. Most patients reached that point within a year. Donanemab is only the second drug that has been convincingly shown to delay the inevitable cognitive decline in patients with Alzheimer’s. The other is Leqembi.The Lilly drug and Leqembi both treat mild or early cases of dementia caused by the fatal disease. The IV drugs target one of Alzheimer’s culprits, sticky amyloid plaque buildup in the brain.
Donanemab, like Leqembi, comes with serious side effects that include brain swelling and bleeding. Those are common to all plaque-targeting drugs and require close monitoring.
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