FDA Approves Donanemab for Early Symptomatic Alzheimer Disease: Daily Dose

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Last week, we reported on the US Food and Drug Administration (FDA) approval of donanemab (Kisunla, Eli Lilly) for the treatment of adults with early symptomatic Alzheimer disease (AD).

The approval

The indication for the once-monthly infusion includes persons with mild cognitive impairment (MCI) as well as those with the mild dementia stage of AD, with confirmed amyloid pathology.

Donanemab is the third antiamyloid therapy to be approved by the FDA, but it is the first with evidence to support limited-duration treatment based on amyloid plaque removal. The approval was supported by data from TRAILBLAZER-ALZ-2, a large-scale, phase 3, double-blind, placebo-controlled trial that enrolled 1736 participants with early-stage AD who were randomly assigned to receive donanemab (n = 860) or placebo (n = 876) every 4 weeks for up to 72 weeks. Results showed that donanemab reduced plaques on average by 61% at 6 months, 81% at 12 months, and 84% at 18 months.

Donanemab is administered monthly as a 350 mg/20mL injection for infusion. The ability to stop therapy can lead to fewer infusions for individuals as well as lower costs for treatment.

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