Kisunla (donanemab) receives full traditional FDA approval for early symptomatic Alzheimer's disease
FDA granted traditional approval to donanemab (Kisunla; Eli Lilly) for adults with early symptomatic Alzheimer's disease — converting the accelerated approval granted in July 2024. The confirmatory TRAILBLAZER-ALZ 2 trial showed a statistically significant 35% slowing of clinical decline on the iADRS composite scale vs placebo at 76 weeks. The label supports treatment discontinuation once amyloid plaque clearance is confirmed by PET or CSF.
Kisunla (donanemab; Eli Lilly) ↗ received accelerated approval from FDA in July 2024 based on amyloid plaque reduction as a surrogate endpoint. On 3 October 2026, FDA granted traditional approval following the confirmatory phase 3 TRAILBLAZER-ALZ 2 trial (NEJM) ↗. Donanemab is an IgG1 monoclonal antibody targeting N3pG amyloid-beta, a post-translationally modified form enriched in plaques.
TRAILBLAZER-ALZ 2 trial results
The trial enrolled 1,736 adults with early symptomatic Alzheimer's disease confirmed by amyloid PET. At 76 weeks, donanemab slowed clinical decline on the integrated Alzheimer's Disease Rating Scale (iADRS) by 35% vs placebo (p<0.001) in the combined tau population. Importantly, 52% of patients achieved complete amyloid clearance (defined as <24.1 Centiloids on PET) by 12 months and were able to discontinue treatment — a key differentiating feature vs lecanemab. Detailed data are in the ClinicalTrials.gov registry (NCT04437511) ↗.
Safety: ARIA and risk stratification
Amyloid-related imaging abnormalities (ARIA) occurred in 36% of donanemab-treated patients vs 15% on placebo — higher rates than seen with lecanemab, attributed to the faster and more complete amyloid clearance. Three deaths related to ARIA occurred in the trial. APOE ε4 homozygotes carry the highest ARIA risk (NCBI) ↗; FDA updated labelling with enhanced APOE genotyping guidance. MRI monitoring at baseline, 4, 8, 12, and 24 weeks after initiation is required. Full safety information is in the DailyMed prescribing information ↗.
Treatment discontinuation — a unique label feature
The Kisunla label explicitly supports discontinuation once amyloid clearance is confirmed on PET imaging or by CSF markers — a first for an anti-amyloid therapy. This reduces total infusion burden and may improve the risk-benefit ratio. The Alzheimer's Association ↗ and American Academy of Neurology ↗ have both updated their practice guidance to incorporate the new approval and the discontinuation criterion.
FAQ
What does FDA approval mean?
FDA approval means the agency has determined, based on scientific evidence submitted by the manufacturer, that a drug's benefits outweigh its known risks for a specific indication and patient population. The review process includes evaluation of clinical trial data, manufacturing quality, and proposed labelling. See the FDA drug approval process overview ↗.
Does approval mean the drug is available immediately?
Not always. Commercial launch timelines depend on manufacturing scale-up, pricing, and distribution. REMS-restricted drugs ↗ require prescriber or pharmacy enrolment before the product can be dispensed. Rare disease drugs may also have limited initial supply. Check the manufacturer's website or RxNav ↗ for availability status.