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
| Date | Article |
|---|
| 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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