FDA record · Alzheimer's disease
What FDA's own documents say about Leqembi: what it is approved for, the trials FDA reviewed, the results it reported and the risks on the label.
“LEQEMBI is indicated for the treatment of Alzheimer's disease.”
Prescribing information, supplement 011 · PDF p. 3 · fda.gov ↗
| Trial | ClinicalTrials.gov | Phase | Mentions | Documents |
|---|---|---|---|---|
| BAN2401-G000-201 | NCT01767311 | 2 | 1,012 | 16 of 28 |
| CLARITY-ADBAN2401-G000-301 | NCT03887455 | 3 | 796 | 14 of 28 |
| BAN2401-J081-104 | NCT02094729 | 1 | 72 | 5 of 28 |
| BAN2401-A001-101 | NCT01230853 | 1 | 58 | 5 of 28 |
| BAN2401-G000-303 | NCT04468659 | 3 | 49 | 5 of 28 |
| BAN2401-A001-004 | NCT05045716 | 1 | 16 | 4 of 28 |
| AHEAD 3 | not given | 8 | 3 of 28 |
Mentions: how many sentences across the FDA documents name the trial. NCT ids are read from the documents or, where they give none, matched on ClinicalTrials.gov by the trial's name or protocol code.
Sentences from FDA's reviews that give an endpoint's p-value, effect or confidence interval, those reporting a treatment effect first.
ADAS-Cog 14
“Lecanemab resulted in a reduction in change from baseline as measured on the ADAS-Cog 14 (-1.442[-26%], p=0.00065), ADCS-ADL-MCI (2.016[-37%], p<0.00001), and ADCOMS (-0.050[-24%], p=0.00002) as compared to placebo.”
Review, supplement 001 · PDF p. 75 · fda.gov ↗
-26%p=0.00065-37%p<0.00001-24%p=0.00002
ADAS-Cog 14
“ADAS-Cog 14 (-1.442[-26%], p=0.00065), ADCS-ADL-MCI (2.016[-37%], p<0.00001), and ADCOMS (-0.050[-24%], p=0.00002) as compared to placebo.”
Review, supplement 001 · PDF p. 115 · fda.gov ↗
-26%p=0.00065-37%p<0.00001-24%p=0.00002
CDR-SB
“The primary efficacy endpoint analysis, change from baseline in CDR-SB at Week 79, demonstrated a statistically significant treatment effect in the lecanemab treatment arm compared to placebo in the FAS+ population (-0.45[-27%], p=0.00005) and the FDA FAS population (-0.39[-25%], p=0.0004) (Table 6)”
Review, supplement 001 · PDF p. 144 · fda.gov ↗
-27%p=0.00005-25%p=0.0004
CDR-SB
“The Study 301 Core met the primary and key secondary endpoints, with statistically significant difference between lecanemab and placebo on change from baseline of CDR-SB at 18 months, demonstrating slowing of disease progression, with an adjusted mean treatment difference of -0.451 (27.1% less decli”
Review, supplement 001 · PDF p. 408 · fda.gov ↗
27.1%P=0.00005adjusted mean treatment difference of -0.451
ADCS-ADL-MCI
“Lecanemab treatment demonstrated a statistically significant reduction in decline on change from baseline ADCS-ADL-MCI compared to placebo in the FAS+ population (2.016 [-37%], p<0.00001) and the FDA FAS population (1.911 [-36%], p<0.00001) (Table 10).”
Review, supplement 001 · PDF p. 152 · fda.gov ↗
-37%p<0.00001-36%
CDR global score
“Lecanemab treatment reduced the risk of progression on the CDR global score by 31% with a hazard ratio of 0.69 (0.572, 0.833), p=0.00011.”
Review, supplement 001 · PDF p. 164 · fda.gov ↗
31%p=0.00011
CLARITY-AD · CDR-SB
“Study 301 core met the primary endpoint of Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) at week 79 (p=0.00005).”
Review, supplement 001 · PDF p. 433 · fda.gov ↗
p=0.00005
amyloid PET
“Adding APOE genotype on baseline amyloid PET and/or drug effect did not provide any statistically significant improvement (p<0.01) to the model, as also suggested by the observed data (Figure 10).”
Review, supplement 001 · PDF p. 430 · fda.gov ↗
p<0.01
“Most common adverse reactions (at approximately 10% and higher incidence compared to placebo): infusion-related reactions, amyloid related imaging abnormality-microhemorrhages, amyloid related imaging abnormality edema/effusion, and headache.”
Prescribing information, supplement 011 · PDF p. 1 · fda.gov ↗
“The recommended dosage is 10 mg/kg administered after dilution as an intravenous infusion over approximately one hour, as follows (2.2): o Once every two weeks for 18 months (2.2) o After 18 months, continue treatment once every 2 weeks or once every 4 weeks (2.2)”
Prescribing information, supplement 013 · PDF p. 1 · fda.gov ↗
| Document | Date | Pages | Copy | sha256 |
|---|---|---|---|---|
| Summary Review761269Orig1s000SumR.pdf | January 6, 2023 | 54 | 5de24982c039 | |
| Prescribing information, original approval761269Orig1s000lbl.pdf | January 6, 2023 | 17 | e1b801ebe601 | |
| Approval letter761269Orig1s000ltr.pdf | January 6, 2023 | 11 | 9cfca3470c37 | |
| Administrative Correspondence761269Orig1s000AdminCorres.pdf | February 6, 2023 | 55 | archived copy | 38f2b917af7a |
| Approval Letter761269Orig1s000Approv.pdf | February 6, 2023 | 14 | archived copy | 08a93adb0617 |
| Chemistry Review761269Orig1s000ChemR.pdf | February 6, 2023 | 15 | archived copy | b33e7f72e9f0 |
| Clinical Pharmacology Review761269Orig1s000ClinPharmR.pdf | February 6, 2023 | 76 | archived copy | 07b599749a4d |
| Prescribing Information (Label)761269Orig1s000Lbl.pdf | February 6, 2023 | 19 | 1c7cbea7f40a | |
| Clinical (Medical) Review761269Orig1s000MedR.pdf | February 6, 2023 | 290 | archived copy | 636fadc1dd6f |
| Proprietary Name Review761269Orig1s000NameR.pdf | February 6, 2023 | 32 | archived copy | 482b8e1f4812 |
| Officer/Employee List761269Orig1s000OEList.pdf | February 6, 2023 | 3 | archived copy | 442ab61833e1 |
| Other Reviews761269Orig1s000OtherR.pdf | February 6, 2023 | 29 | archived copy | 1ff20545a8fa |
| Pharmacology/Toxicology Review761269Orig1s000PharmR.pdf | February 6, 2023 | 33 | 0a2850099751 | |
| Risk Assessment / REMS Review761269Orig1s000RiskR.pdf | February 6, 2023 | 17 | bc9e4a30b283 | |
| Statistical Review761269Orig1s000StatR.pdf | February 6, 2023 | 49 | 3801dd3db168 | |
| Prescribing information, supplement 001761269Orig1s001lbl.pdf | September 5, 2023 | 23 | d1908d5e122b | |
| Approval letter, supplement 001761269Orig1s001ltr.pdf | September 5, 2023 | 17 | bd7bec6c00cd | |
| Review, supplement 001761269Orig1s001.pdf | April 9, 2024 | 495 | e74fb0d9c8a0 | |
| Prescribing information, supplement 008761269s008lbl.pdf | November 15, 2024 | 22 | 710060ee1038 | |
| Approval letter, supplement 008761269Orig1s008ltr.pdf | November 15, 2024 | 4 | d01287a33a91 | |
| Prescribing information, supplement 005761269s005lbl.pdf | February 5, 2025 | 23 | ac68016a27e8 | |
| Approval letter, supplement 005761269Orig1s005ltr.pdf | February 6, 2025 | 4 | d6b97da5499f | |
| Approval letter, supplement 013716269Orig1s013ltr.pdf | August 22, 2025 | 4 | archived copy | b98cb0a6f5bf |
| Prescribing information, supplement 013761269s013lbl.pdf | August 25, 2025 | 23 | d04de061481a | |
| Prescribing information, supplements 012 and 015761269s012s015lbl.pdf | December 18, 2025 | 38 | 796b9deae3aa | |
| Approval letter, supplements 012 and 015761269Orig1s012_s015ltr.pdf | December 22, 2025 | 4 | d2983146667f | |
| Prescribing information, supplement 011761269s011lbl.pdf | January 21, 2026 | 38 | 9635683bd78e | |
| Approval letter, supplement 011761269Orig1s011ltr.pdf | January 22, 2026 | 4 | d835ded46715 |
Checked against FDA's copies on September 30, 2026. The sha256 is the fingerprint of the file that was read: download it from fda.gov and compare. Quotes come from the text of each file as read; pages FDA stored as images were read by OCR and are marked.
Generated automatically (auto): the trials, names and dates are drafted from the documents by rules, with no language model; see the method.