Kevzara Approval History
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 receptor (IL-6R) antibody for the treatment of adults with rheumatoid arthritis.
Development History and FDA Approval Process for Kevzara
|May 22, 2017|| Sanofi and Regeneron Announce FDA Approval of Kevzara (sarilumab) for Rheumatoid Arthritis|
|Apr 28, 2017||Sanofi and Regeneron Announce Kevzara (sarilumab) Biologics License Application Resubmission Accepted for Review by US FDA|
|Nov 16, 2016||Sanofi and Regeneron Present Results from Phase 3 MONARCH Study of Investigational Sarilumab |
|Oct 28, 2016||Sanofi and Regeneron Receive Complete Response Letter from FDA for Sarilumab, an Investigational Treatment for Rheumatoid Arthritis|
|Mar 11, 2016||Sanofi and Regeneron Announce Topline Results of Phase 3 Monotherapy Study Demonstrating Superiority of Sarilumab Vs. Adalimumab in Patients with Active Rheumatoid Arthritis|
|Jan 8, 2016||Sanofi and Regeneron Announce Sarilumab BLA Accepted for Review by FDA|
|Nov 8, 2015||Sanofi and Regeneron Present Results From Pivotal Phase 3 Study of Sarilumab at American College of Rheumatology Annual Meeting|
|May 21, 2015||Sanofi And Regeneron Announce Positive Topline Results From Phase 3 Studies With Sarilumab In Rheumatoid Arthritis|
|Nov 22, 2013||Sanofi and Regeneron Report Positive Results with Sarilumab|
|May 15, 2013||Sanofi and Regeneron Announce Patient Enrollment in Two Phase 3 Trials with Sarilumab in Rheumatoid Arthritis (RA)|
|Oct 27, 2011||Positive 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, 2011||Sanofi and Regeneron Report Positive Phase 2b Trial Results with Sarilumab in Rheumatoid Arthritis|
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