Kevzara FDA Approval History
Last updated by Judith Stewart, BPharm on June 18, 2024.
FDA Approved: Yes (First approved May 22, 2017)
Brand name: Kevzara
Generic name: sarilumab
Dosage form: Injection
Company: Sanofi and Regeneron Pharmaceuticals, Inc.
Treatment for: Rheumatoid Arthritis, Polymyalgia Rheumatica, Polyarticular Juvenile Idiopathic Arthritis
Kevzara (sarilumab) is an interleukin-6 (IL-6) receptor antagonist for the treatment of rheumatoid arthritis, polymyalgia rheumatica and polyarticular juvenile idiopathic arthritis.
- Kevzara is indicated for the 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). - Kevzara works by binding specifically to the IL-6 receptor and has been shown to inhibit IL-6-mediated signaling. IL-6 is an immune system protein produced in increased quantities in patients with rheumatoid arthritis and has been associated with disease activity, joint destruction and other systemic problems.
- Kevzara is also being evaluated in a global clinical trial program as a potential treatment for patients who are hospitalized with COVID-19. Scientists have preliminary evidence that IL-6 may play a key role in driving the inflammatory immune response that causes acute respiratory distress syndrome (ARDS) in critically ill COVID-19 patients.
- Kevzara is administered by subcutaneous injection, once every 2 weeks.
- Warnings and precautions associated with Kevzara include serious infections; neutropenia, thrombocytopenia, elevated liver enzymes, and lipid abnormalities; increased risk of gastrointestinal perforation; and hypersensitivity reactions.
- Common adverse reactions:
- in rheumatoid arthritis patients include neutropenia, increased ALT, injection site erythema, upper respiratory infections and urinary tract infections.
- in polymyalgia rheumatica patients include neutropenia, leukopenia and injection site pruritus.
- in polyarticular juvenile idiopathic arthritis patients include nasopharyngitis, neutropenia, upper respiratory tract infection and injection site erythema.
Development timeline for Kevzara
Further information
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