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Kevzara Approval History

  • FDA approved: Yes (First approved May 22nd, 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 receptor (IL-6R) antibody for the treatment of adults with rheumatoid arthritis.

Development History and FDA Approval Process for Kevzara

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
Nov 16, 2016Sanofi and Regeneron Present Results from Phase 3 MONARCH Study of Investigational Sarilumab
Oct 28, 2016Sanofi and Regeneron Receive Complete Response Letter from FDA for Sarilumab, an Investigational Treatment for Rheumatoid Arthritis
Mar 11, 2016Sanofi and Regeneron Announce Topline Results of Phase 3 Monotherapy Study Demonstrating Superiority of Sarilumab Vs. Adalimumab in Patients with Active Rheumatoid Arthritis
Jan  8, 2016Sanofi and Regeneron Announce Sarilumab BLA Accepted for Review by FDA
Nov  8, 2015Sanofi and Regeneron Present Results From Pivotal Phase 3 Study of Sarilumab at American College of Rheumatology Annual Meeting
May 21, 2015Sanofi And Regeneron Announce Positive Topline Results From Phase 3 Studies With Sarilumab In Rheumatoid Arthritis
Nov 22, 2013Sanofi and Regeneron Report Positive Results with Sarilumab
May 15, 2013Sanofi and Regeneron Announce Patient Enrollment in Two Phase 3 Trials with Sarilumab in Rheumatoid Arthritis (RA)
Oct 27, 2011Positive Phase 2b Results with Sarilumab in Rheumatoid Arthritis to be Presented as a Late-Breaking Poster at the 2011 American College of Rheumatology Annual Meeting
Jul 13, 2011Sanofi and Regeneron Report Positive Phase 2b Trial Results with Sarilumab in Rheumatoid Arthritis

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