Skip to main content

Kevzara FDA Approval History

Last updated by Judith Stewart, BPharm on March 19, 2023.

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

Kevzara (sarilumab) is an interleukin-6 (IL-6) receptor antagonist for the treatment of rheumatoid arthritis and polymyalgia rheumatica.

  • 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); and for the treatment of adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper.
  • 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.
    Common adverse reactions in polymyalgia rheumatica patients include neutropenia, leukopenia and injection site pruritus.

Development timeline for Kevzara

Feb 28, 2023Approval Kevzara (sarilumab) Approved by FDA as First and Only Biologic Indicated for Patients with Polymyalgia Rheumatica
Apr 28, 2020Sanofi and Regeneron Provide Update on U.S. Kevzara Phase 2/3 Adaptive-Designed Trial in Hospitalized COVID-19 Patients
Mar 30, 2020First Patient Outside U.S. Treated in Global Kevzara® (sarilumab) Clinical Trial Program for Patients with Severe COVID-19
Mar 16, 2020Sanofi and Regeneron Begin Global Kevzara® (sarilumab) Clinical Trial Program in Patients with Severe COVID-19
May 22, 2017Approval Sanofi and Regeneron Announce FDA Approval of Kevzara (sarilumab) for Rheumatoid Arthritis
Apr 28, 2017Sanofi and Regeneron Announce Kevzara (sarilumab) Biologics License Application Resubmission Accepted for Review by US FDA
Oct 28, 2016Sanofi and Regeneron Receive Complete Response Letter from FDA for Sarilumab, an Investigational Treatment for Rheumatoid Arthritis
Jan  8, 2016Sanofi and Regeneron Announce Sarilumab BLA Accepted for Review by FDA

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.