Treats severe asthma and with an eosinophilic phenotype. BLA 761122, held by Glaxosmithkline. Mepolizumab.
As of Nov 13, 2026, BLA 761122 (Nucala), held by Glaxosmithkline, was first approved by FDA on Jun 6, 2019, with 7 approved supplements and 0 published complete response letters.
NUCALA is an interleukin-5 (IL-5) antagonist monoclonal antibody (IgG1 kappa) indicated for:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 29, 2021 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Sep 12, 2019 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Jun 6, 2019 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nucala100MG/ML · injectable;subcutaneous | Mepolizumab | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 6, 2025 | Supplement 22Labeling · Standard review | Approved | |
| Mar 8, 2023 | Supplement 11Labeling · Standard review | Approved | |
| Jan 22, 2022 | Supplement 8Manufacturing | Approved | |
| Jul 29, 2021 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Sep 25, 2020 | Supplement 5Labeling · Standard review | Approved | |
| Sep 12, 2019 | Supplement 2Labeling · Standard review | Approved | |
| Sep 12, 2019 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Jun 6, 2019 | Original applicationNew dosage form · Standard 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
