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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.

Development timeline for Kevzara

Jun 11, 2024Approval FDA Approves Kevzara (sarilumab) for the Treatment of Active Polyarticular Juvenile Idiopathic Arthritis (pJIA)
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

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