The approval of Kisunla (350mg/20mL, IV, QM) for early symptomatic Alzheimer’s disease was based on P-III (TRAILBLAZER-ALZ 2) study. Coverage & reimbursement is available through National Coverage Determination with Coverage with Evidence Development
The P-III (TRAILBLAZER-ALZ 2) trial assessed Kisunla vs PBO in patients (n=1,736) with early symptomatic AD (MCI or mild dementia) & confirmed Alzheimer’s pathology in 2 groups, one with less advanced disease & other having overall population
Results depicted a 35% slow decline in less advanced Alzheimer’s patients & 22% in the overall population on the iADRS, with a 39% reduced risk of progression to the next clinical stage. Amyloid plaques were reduced by 61% (6mos.), 80% (12mos.) & 84% (18mos.) in the overall population
Ref: Eli Lilly | Image: Eli Lilly
Related News: Eli Lilly Reports P-III (TRAILBLAZER-ALZ 4) Study Results of Donanemab for the Treatment of Early Symptomatic Alzheimer’s Disease
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