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# FDA OKs New Lilly Alzheimer’s Drug
- URL: https://www.fdaweb.com/fda-oks-new-lilly-alzheimers-drug/
- Published: 2024-07-08T12:00:00.000Z
- Updated: 2026-09-14T14:34:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157290

FDA has approved Lilly’s Kisunla (donanemab-azbt) injection to treat Alzheimer’s disease. An agency [statement](https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-adults-alzheimers-disease?ref=fdaweb.com) says treatment with Kisunla should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which the drug was studied in clinical trials.

Kisunla is administered as an injection every four weeks. Its efficacy was evaluated in a parallel-group study of patients with Alzheimer’s disease. FDA says patients treated with Kisunla demonstrated a statistically significant reduction in clinical decline.

The drug’s labeling includes a Boxed Warning for amyloid-related imaging abnormalities (ARIA), which most commonly presents as temporary swelling in areas of the brain that usually resolve over time and may be accompanied by small spots of bleeding in or on the surface of the brain, FDA says. The agency says the most common Kisunla side effects were ARIA and headache.

FDA granted the Lilly application fast track, priority review, and breakthrough therapy designations.