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The U.S. Food and Drug Administration granted approval of donanemab on Tuesday for patients in early stages of Alzheimer's disease, marking the second approved drug aimed at slowing progression of the neurodegenerative condition.
Branded as Kisunla (Eli Lilly), the approval aligns with recommendations from the agency's external experts, who unanimously supported its use for early Alzheimer's patients, citing favorable benefit-risk profiles.
Clinical trial date showed “convincingly, that Kisunla reduces the rate of cognitive and functional decline in patients in the mild cognitive impairment and mild dementia stages of Alzheimer’s disease," said Teresa Buracchio, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. The "approval is evidence of the FDA’s commitment to helping more safe and effective drugs to treat Alzheimer’s disease become available.”
Lilly has set the price of Kisunla at $695.65 per vial, totaling $32,000 for a 12-month treatment course.
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