The U.S. Food and Drug Administration has approved Eli Lilly’s Kisunla (donanemab-azbt) injection, a new treatment for Alzheimer’s disease. Targeted at adults in the mild cognitive impairment or mild dementia stage, Kisunla has shown significant promise in slowing clinical decline, offering a new beacon of hope for patients and their families.
The approval comes after a double-blind, placebo-controlled, parallel-group study (Study 1, NCT04437511) in patients with Alzheimer’s disease. The patients had confirmed the presence of amyloid pathology and mild cognitive impairment or mild dementia stage of disease. 1736 patients were randomised 1:1 to receive 700 mg Kisunla every four weeks for the first 3 doses, and then 1400 mg every four weeks (N = 860) or placebo (N = 876) for a total of up to 72 weeks. The treatment was switched to placebo based on a prespecified reduction in amyloid levels measured by positron emission tomography (PET) at Week 24, Week 52, and Week 76.
“Patients treated with Kisunla demonstrated a statistically significant reduction in clinical decline on the Integrated Alzheimer’s Disease Rating Scale (iADRS) compared to placebo at Week 76 in the overall population (2.92, p<0.0001), as well as on the iADRS component scales, the Alzheimer’s Disease Assessment Scale-Cognitive subscale (ADAS-Cog13) (-1.33, p=0.0006) and the Alzheimer’s Disease Cooperative Study – instrumental Activities of Daily Living (ADCS-iADL) scale (1.70, p=0.0001),” informed the statement published by US FDA.
Patients treated with Kisunla also demonstrated a statistically significant reduction in clinical decline on the Clinical Dementia Rating Scale – Sum of Boxes (CDR-SB) compared to placebo at Week 76 in the overall population (-0.70, p<0.0001).
“The trial data demonstrated, 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.
At baseline, the study population had a mean age of 73 years, with a range of 59 to 86 years. Fifty-seven percent of patients were female, 91 per cent were White, 6 per cent were Asian, 4 per cent were Hispanic or Latino, and 2 per cent were Black or African American. White, 6 per cent were Asian, 4 per cent were Hispanic or Latino, and 2 per cent were Black or African American.
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