Subjects ” Alzheimer’s and dementia
The Food and Drug Administration (FDA) has granted Donanemab Breakthrough Therapy status for the treatment of Alzheimer’s disease.
Donanemab is an antibody therapy under investigation that targets a modified form of the deposited amyloid-β peptide called N3pG. The designation is based on data from the phase 2 study TRAILBLAZER-ALZ (ClinicalTrials.gov Identifier: NCT03367403), which examined the efficacy and safety of donanemab in 257 patients with early symptomatic Alzheimer’s disease with dew and amyloid deposits. Patients were randomized 1: 1 to receive intravenous donanemab or placebo every 4 weeks for up to 72 weeks.
The results showed that treatment with Donanemab, based on the change from baseline on the Integrated Alzheimer’s Disease Rating Scale (-6.86 vs. -10.06 for placebo; difference 3.20; 95% CI 0.12- 6.27; P = 0.04) resulted in a smaller decrease, a composite tool that combines the Alzheimer Disease Assessment Scale-Cognitive subscale and the Alzheimer Disease Cooperative Study – Instrumental Activities of Daily Living for Function. No significant differences were observed for most of the secondary endpoints, including scores for dementia, cognition, everyday life, and mental health.
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The company plans to submit a Biologics (BLA) application for Donanemab later this year as part of the accelerated approval process. Donanemab is currently being investigated in the ongoing, multicenter, randomized, double-blind, placebo-controlled phase 3 study TRAILBLAZER-ALZ 2 (ClinicalTrials.gov Identifier: NCT04437511) for early-stage Alzheimer’s disease.
References
- Lilly’s Donanemab has been granted Breakthrough Therapy status by the US FDA for the treatment of Alzheimer’s disease. [press release]. Indianapolis, IN: Eli Lilly and Company; 06/24/2021.
- Mintun MA, Lo AC, Evans CD, et al. Donanemab in early Alzheimer’s disease. N Engl J Med. Published online May 6, 2021. doi: 10.1056 / NEJMoa2100708.
This article originally appeared on MPR
Subjects:
Treatment of Alzheimer’s disease and dementia for cognitive impairment
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