Eli Lilly Reports Kisunla (Donanemab) Approval in the EU to Treat Early Symptomatic Alzheimer’s Disease
Shots:
- The EC has approved Kisunla to treat early symptomatic Alzheimer’s disease in adults with mild impairment or dementia & confirmed amyloid pathology who are ApoE4 heterozygotes or non-carriers
- Approval was based on P-III (TRAILBLAZER-ALZ 2) study (n=1736, ≥18mos.) & P-IIIb (TRAILBLAZER-ALZ 6) trial (n=843, 60-85yrs.) assessing Kisunla (QM) vs PBO in AD pts
- The TRAILBLAZER-ALZ 2 trial showed Kisunla slowed cognitive & functional decline, while TRAILBLAZER-ALZ 6 supported a gradual titration dosing that reduced ARIA-E at 24/52wks. yet maintained comparable amyloid plaque removal & P-tau217 reduction
Ref: Eli Lilly | Image: Eli Lilly| Press Release
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