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Kevzara FDA Approval History

Last updated by Judith Stewart, BPharm on April 8, 2020.

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

Kevzara (sarilumab) is an interleukin-6 (IL-6) receptor antagonist indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs).

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.

Development Timeline for Kevzara

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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