Treats moderately to severely active rheumatoid arthritis. BLA 125433, held by Janssen Biotech. Golimumab.
As of Nov 13, 2026, BLA 125433 (Simponi Aria), held by Janssen Biotech, was first approved by FDA on Jul 18, 2013, with 17 approved supplements and 0 published complete response letters.
SIMPONI ARIA is a tumor necrosis factor (TNF) blocker indicated for the treatment of: Adult patients with moderately to severely active Rheumatoid Arthritis (RA) in combination with methotrexate Active Psoriatic Arthritis (PsA) in patients 2 years of age and older Adult patients with active Ankylosing Spondylitis (AS) Active polyarticular Juvenile Idiopathic Arthritis (pJIA) in patients 2 years of age and older 1.1 Rheumatoid Arthritis (RA) SIMPONI ARIA, in combination with methotrexate (MTX), is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 1, 2021 | Supplement 32Efficacy (new indication or use) · Standard review | Approved | |
| Sep 29, 2020 | Supplement 30Efficacy (new indication or use) · Standard review | Approved | |
| Sep 29, 2020 | Supplement 31Efficacy (new indication or use) · Standard review | Approved | |
| Oct 20, 2017 | Supplement 20Efficacy (new indication or use) · Standard review | Approved | |
| Oct 20, 2017 | Supplement 21Efficacy (new indication or use) · Standard review | Approved | |
| Aug 5, 2015 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Jul 18, 2013 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Simponi Aria50MG/4ML · injectable; injection | Golimumab | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 18, 2025 | Supplement 36Labeling · Standard review | Approved | |
| Feb 1, 2021 | Supplement 32Efficacy (new indication or use) · Standard review | Approved | |
| Sep 29, 2020 | Supplement 30Efficacy (new indication or use) · Standard review | Approved | |
| Sep 29, 2020 | Supplement 31Efficacy (new indication or use) · Standard review | Approved | |
| Sep 24, 2019 | Supplement 28Labeling · Standard review | Approved | |
| Feb 9, 2018 | Supplement 24Labeling · Standard review | Approved | |
| Oct 20, 2017 | Supplement 20Efficacy (new indication or use) · Standard review | Approved | |
| Oct 20, 2017 | Supplement 21Efficacy (new indication or use) · Standard review | Approved | |
| Jan 30, 2017 | Supplement 19Labeling · Standard review | Approved | |
| Aug 19, 2016 | Supplement 18Labeling · Standard review | Approved | |
| Apr 26, 2016 | Supplement 16Labeling · Standard review | Approved | |
| Feb 22, 2016 | Supplement 17Labeling · Standard review | Approved | |
| Jan 8, 2016 | Supplement 15Labeling · Standard review | Approved | |
| Aug 5, 2015 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Dec 19, 2014 | Supplement 13Labeling · Standard review | Approved | |
| Feb 12, 2014 | Supplement 5Labeling · Standard review | Approved | |
| Feb 4, 2014 | Supplement 2Labeling · Standard review | Approved | |
| Jul 18, 2013 | Original application | 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
