Treats Alzheimer’s disease. BLA 761375, held by Eisai Inc. Lecanemab-Irmb.
As of Nov 13, 2026, BLA 761375 (Leqembi Iqlik), held by Eisai Inc, was first approved by FDA on Aug 29, 2025, with 1 approved supplement 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 |
|---|---|---|---|
| Jul 13, 2026 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| Aug 29, 2025 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Leqembi Iqlik360MG/1.8ML(200MG/ML) · injectable;subcutaneous | Lecanemab-Irmb | Rx |
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
