What the sponsor asked the agency to accept
As the FDA restates it.
The Applicant is seeking traditional approval based primarily on results from Study AACI, a multicenter, randomized, double-blind, placebo-controlled, parallel group study in subjects with early symptomatic Alzheimer’s disease.
Summary review · PDF p. 3 · action of · fda.gov ↗
What the agency said
T2 · Effect sizeConsistent
KIS-T2-1
The effect on the ADAS-cog, iADL, and CDR-SB endpoints in Study AACI represent a clinically meaningful reduction of clinical decline.
Summary review · PDF p. 4 · action of · fda.gov ↗
Compared to LQT-T2-1, Leqembi, traditional approval, .
T3 · ARIAConsistent
KIS-T3-1
The incidence of ARIA in AACI was higher in ApoE ε4 homozygotes (55% on donanemab vs. 22% on placebo) than in heterozygotes (36% on donanemab vs 13% on placebo) and noncarriers (25% on donanemab vs 12% on placebo).
Summary review · PDF p. 6 · action of · fda.gov ↗
Compared to LQT-T3-1, Leqembi, traditional approval, .
T4 · DataConsistent
KIS-T4-1
The safety of donanemab was characterized in a safety database of adequate size.
Summary review · PDF p. 5 · action of · fda.gov ↗
Compared to DON-T4-1, Donanemab, complete response letter, .
T4 · DataConsistent
KIS-T4-2
Together, the results of these two adequate and well-controlled studies, AACI and AACG, provide substantial evidence of effectiveness for donanemab for the treatment of Alzheimer’s disease.
Summary review · PDF p. 4 · action of · fda.gov ↗
Compared to LQT-T4-1, Leqembi, traditional approval, .
Committee votes
Peripheral and Central Nervous System Drugs Advisory Committee, . Read from Advisory committee minutes (June 10, 2024), which reproduces the questions and results.
| Question | Yes | No | Abstain | Source |
|---|---|---|---|---|
| Q2 Do the available data show that donanemab is effective for the treatment of Alzheimer’s disease in the population enrolled in the clinical trials with mild cognitive impairment and mild dementia? | 11 | 0 | 0 | p. 5 ↗ |
| Q5 Do the benefits outweigh the risks of donanemab in the treatment of AD in the population enrolled in the clinical trials with mild cognitive impairment and mild dementia? | 11 | 0 | 0 | p. 6 ↗ |