Eli Lilly's Kisunla (Donanemab-azbt) Receives the MHLW’s Approval for Treating Early Symptomatic Alzheimer's Disease (AD)
Shots:
- The MHLW has approved Kisunla (350mg/20mL, IV, Q4W) to treat early symptomatic AD, incl. mild cognitive impairment & mild dementia stages, with confirmed amyloid pathology
- Approval was based on P-III (TRAILBLAZER-ALZ 2) trial assessing Kisunla in patients (n=1,736) with early symptomatic AD (MCI or mild dementia due to AD) with confirmed amyloid pathology. Results were published in the JAMA
- Study depicted slowing of disease decline by 35% in less advanced Alzheimer's patients & 22% in the overall group, reduced risk of progression by 39% & lowered amyloid plaques by 61% at 6mos., 80% at 12mos. & 84% at 18mos. 66% of patients had plaque clearance at 1yr., allowing some to switch to PBO for the rest of the study
Ref: Eli Lilly | Image: Eli Lilly
Related News: Eli Lilly Reports the US FDA’s Approval of Kisunla (donanemab-azbt) to Treat Early Symptomatic Alzheimer's Disease
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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.