LLY - Eli Lilly's Alzheimer's Therapy's Broad Label Reflects Regulatory Confidence in Anti-Amyloid Antibodies: Analyst | Benzinga
On Tuesday, the FDA approved Eli Lilly and Co’s (NYSE:LLY) Kisunla (donanemab) once-monthly injection for IV infusion) for adults with early symptomatic Alzheimer’s disease.
Once-monthly, Kisunla is the first and only amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed, which can result in lower treatment costs and fewer infusions.
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Amyloid is a protein produced naturally in the body that can clump together to create amyloid plaques. The excessive buildup of amyloid plaques in the brain may lead to memory and thinking issues associated with Alzheimer’s disease.
In the TRAILBLAZER-ALZ 2 Phase 3 study, individuals treated with Kisunla who were less advanced in their disease showed a 35% reduction in decline compared with placebo on the integrated Alzheimer’s Disease Rating Scale (iADRS), which measures memory, thinking, and daily functioning.
The overall population’s response to treatment was also statistically significant using the iADRS at 22%.
Among the two groups analyzed, participants treated with Kisunla had up to a 39% lower risk of progressing to the next clinical stage of disease than those taking ...