Treats moderately to severely active rheumatoid arthritis. BLA 761037, held by Sanofi Synthelabo. Sarilumab.
As of Nov 13, 2026, BLA 761037 (Kevzara), held by Sanofi Synthelabo, was first approved by FDA on May 22, 2017, with 3 approved supplements and 0 published complete response letters.
KEVZARA is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. patients who weigh 63 kg or greater with active polyarticular juvenile idiopathic arthritis (pJIA). 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 10, 2024 | Supplement 15Efficacy (new indication or use) · Standard review | Approved | |
| Feb 28, 2023 | Supplement 13Efficacy (new indication or use) · Priority review | Approved | |
| Apr 13, 2018 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| May 22, 2017 | 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
