BLA 761279, held by Eli Lilly And Co. Mirikizumab-Mrkz.
As of Nov 13, 2026, BLA 761279 (Omvoh), held by Eli Lilly And Co, was first approved by FDA on Oct 26, 2023, with 4 approved supplements and 1 published complete response letter.
OMVOH is indicated for the treatment of: moderately to severely active ulcerative colitis in adults. moderately to severely active Crohn's disease in adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 15, 2025 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Jan 15, 2025 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Oct 26, 2023 | Original applicationNew molecular entity · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Mar 30, 2023 | LY3074828Facility Inspections, Microbiology, Product Quality | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Omvoh300MG/15ML · vial; single-use | Mirikizumab-Mrkz | Rx |
| Omvoh100MG/ML · injectable;subcutaneous | Mirikizumab-Mrkz | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 23, 2025 | Supplement 5Labeling · Standard review | Approved | |
| Jan 15, 2025 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Jan 15, 2025 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Apr 29, 2024 | Supplement 1Labeling · Standard review | Approved | |
| Oct 26, 2023 | Original applicationNew molecular entity · 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
