FDA record · Alzheimer's disease
What FDA's own documents say about Kisunla: what it is approved for, the trials FDA reviewed, the results it reported and the risks on the label.
“KISUNLA is an amyloid beta-directed antibody indicated for the treatment of Alzheimer's disease.”
Prescribing information, supplement 004 · PDF p. 1 · fda.gov ↗
| Trial | ClinicalTrials.gov | Phase | Mentions | Documents |
|---|---|---|---|---|
| TRAILBLAZER-ALZ 2I5T-MC-AACI | NCT04437511 | 3 | 1,186 | 11 of 18 |
| I5T-MC-AACG | NCT03367403 | 2 | 701 | 8 of 18 |
| I5T-MC-AACH | NCT04640077 | 2 | 32 | 5 of 18 |
| I5T-MC-AACD | not given | 31 | 4 of 18 | |
| I5T-MC-AACN | NCT05108922 | 3 | 23 | 2 of 18 |
| I5T-MC-AACC | not given | 16 | 3 of 18 | |
| TRAILBLAZER-ALZ 3 | not given | 4 | 3 of 18 | |
| 15T-MC-AAAG | not given | 1 | 1 of 18 |
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.
CDR-SB
“Statistically significant reduction in clinical decline in the Division's recommended endpoint, CDR-SB, was also demonstrated, with a treatment effect of -0.70 [-29%], p<0.001 in the combined population.”
Summary Review · PDF p. 4 · fda.gov ↗
treatment effect of -0.70-29%p<0.001
ADAS-Cog 13
“Statistically significant results favoring donanemab were observed for the multiplicity-controlled secondary endpoints ADAS-Cog 13 (-1.33 [-20%], p<0.001) and ADCS-iADL (1.70 [-28%], p<0.001) that are components of the iADRS.”
Summary Review · PDF p. 4 · fda.gov ↗
-20%p<0.001-28%
CDR-SB
“Donanemab treatment demonstrated a statistically significant reduction in decline on change from baseline CDR-SB compared to placebo in the low/medium tau population (-0.67 [-36%], p<0.001) and the overall population (-0.70 [-29%], p<0.001).”
Summary Review · PDF p. 27 · fda.gov ↗
-36%p<0.001-29%
ADAS-Cog 13
“ADAS-Cog 13 compared to placebo in the low/medium tau population (-1.52 [-32%], p<0.001) and the overall population (-1.33 [-20%], p<0.001).”
Summary Review · PDF p. 29 · fda.gov ↗
-32%p<0.001-20%
CDR global score
“Donanemab treatment reduced the risk of progression on the CDR global score by 39% with a hazard ratio of 0.61 (0.47, 0.80), p<0.001 in the low/medium population and by 37% with a hazard ratio of 0.63 (0.51, 0.77), p<0.0001 in the overall population.”
Summary Review · PDF p. 29 · fda.gov ↗
39%p<0.001
MMSE
“Results for MMSE showed less change from baseline at Week 76 in the donanemab treatment group than in subjects on placebo in the low/medium tau population (0.48 [-23%], 95% CI [0.09, 0.87]) and the overall population (0.47 [-16%], 95% CI [0.10, 0.84]).”
Summary Review · PDF p. 29 · fda.gov ↗
-23%95% CI [0.09, 0.87]
amyloid PET
“There was a significant correlation between change from baseline in plasma p-tau 217 and percent change in amyloid PET from baseline (R=0.484, p<0.0001).”
Summary Review · PDF p. 89 · fda.gov ↗
p<0.0001
amyloid PET
“There was a significant correlation between change from baseline in GFAP and percent change in amyloid PET from baseline (R=0.453, p<0.0001).”
Summary Review · PDF p. 89 · fda.gov ↗
p<0.0001
“Most common adverse reactions (at least 10% and higher incidence compared to placebo): ARIA-E, ARIA-H microhemorrhage, ARIA-H superficial siderosis, and headache.”
Prescribing information, supplement 004 · PDF p. 1 · fda.gov ↗
“Administer KISUNLA every four weeks as an intravenous infusion over approximately 30 minutes with the recommended dosage and dosing schedule described in Table 1. KISUNLA must be diluted prior to administration (see Table 4).”
Prescribing information, supplement 004 · PDF p. 2 · fda.gov ↗
| Document | Date | Pages | Copy | sha256 |
|---|---|---|---|---|
| Prescribing information, original approval761248s000lbl.pdf | July 3, 2024 | 17 | 54cd9855816a | |
| Approval letter761248Orig1s000ltr.pdf | July 5, 2024 | 11 | f88317e72528 | |
| Administrative Correspondence761248Orig1s000AdminCorres.pdf | July 29, 2024 | 60 | archived copy | 90e1bc2107f5 |
| Approval Letter761248Orig1s000Approv.pdf | July 29, 2024 | 14 | archived copy | 5ff98bbcd551 |
| Chemistry Review761248Orig1s000ChemR.pdf | July 29, 2024 | 40 | 49e4278a19d5 | |
| Clinical Pharmacology Review761248Orig1s000ClinPharmR.pdf | July 29, 2024 | 165 | archived copy | 0c6b20f1345f |
| Prescribing Information (Label)761248Orig1s000Lbl.pdf | July 29, 2024 | 19 | archived copy | 632dbc25278b |
| Clinical (Medical) Review761248Orig1s000MedR.pdf | July 29, 2024 | 621 | 93bdf1fad077 | |
| Proprietary Name Review761248Orig1s000NameR.pdf | July 29, 2024 | 50 | 2d2b42ab4444 | |
| Officer/Employee List761248Orig1s000OEList.pdf | July 29, 2024 | 2 | e4425a36e81d | |
| Other Action Letters761248Orig1s000OtherActionLtrs.pdf | July 29, 2024 | 8 | archived copy | e9314cbe6375 |
| Other Reviews761248Orig1s000OtherR.pdf | July 29, 2024 | 72 | c56b5f411c8d | |
| Pharmacology/Toxicology Review761248Orig1s000PharmR.pdf | July 29, 2024 | 22 | 23e5f8ca8f94 | |
| Risk Assessment / REMS Review761248Orig1s000RiskR.pdf | July 29, 2024 | 24 | b5583995c8c6 | |
| Statistical Review761248Orig1s000StatR.pdf | July 29, 2024 | 111 | 024565fe8c12 | |
| Summary Review761248Orig1s000SumR.pdf | July 29, 2024 | 113 | bb9356f5158a | |
| Prescribing information, supplement 004761248s004lbl.pdf | July 2, 2025 | 19 | 11d8cf8466a1 | |
| Approval letter, supplement 004761248Orig1s004ltr.pdf | July 2, 2025 | 4 | 68693e8dc131 |
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.