Treats Alzheimer’s disease. BLA 761269, held by Eisai Inc. Lecanemab-Irmb.
As of Nov 13, 2026, BLA 761269 (Leqembi), held by Eisai Inc, was first approved by FDA on Jan 6, 2023, with 7 approved supplements and 0 published complete response letters.
LEQEMBI is indicated for the treatment of Alzheimer’s disease. Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 24, 2025 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Jul 6, 2023 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| Jan 6, 2023 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Leqembi500MG/5ML · injectable;injection | Lecanemab-Irmb | Rx |
| Leqembi200MG/2ML · injectable;injection | Lecanemab-Irmb | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 16, 2026 | Supplement 11Labeling · Standard review | Approved | |
| Dec 15, 2025 | Supplement 12Labeling · Standard review | Approved | |
| Dec 15, 2025 | Supplement 15Labeling · Standard review | Approved | |
| Aug 21, 2025 | Supplement 13Labeling · Standard review | Approved | |
| Jan 24, 2025 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Nov 14, 2024 | Supplement 8Labeling · Standard review | Approved | |
| Jul 6, 2023 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| Jan 6, 2023 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
