Eli Lilly Reports the US FDA’s Approval of Kisunla (donanemab-azbt) to Treat Early Symptomatic Alzheimer's Disease
Shots:
- 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
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
