Eli Lilly's Alzheimer's medication, Donanemab, now branded as Kisunla, received FDA approval on Tuesday, becoming the third drug approved for Alzheimer's in the last three years. These medications target amyloid beta protein plaques in the brain, which disrupt brain function. Kisunla stands out as it permits treatment cessation once these plaques are eliminated. It is administered as an intravenous infusion every four weeks and is effective in the early stages of Alzheimer's, specifically for patients with mild cognitive impairment or mild dementia.
Dr. MV Padma Srivastava emphasized the increasing global burden of Alzheimer's, stressing the importance of such treatments despite their high costs, which might decrease as more manufacturers enter the market.
Kisunla's prescribing information includes a boxed warning for amyloid-related imaging abnormalities (ARIA). In phase III trials, 24% of participants experienced brain swelling, and 19.7% had brain bleeds, with three treatment-related deaths reported.
Nevertheless, the study demonstrated that Kisunla slowed cognitive decline by 35.1% over 76 weeks in early Alzheimer's patients, offering a significant advancement in the treatment of this debilitating disease.
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