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Sarilumab Approval Status

  • FDA approved: No
  • Generic name: sarilumab
  • Company: Sanofi and Regeneron Pharmaceuticals, Inc.
  • Treatment for: Rheumatoid Arthritis

Sarilumab is an investigational interleukin-6 receptor (IL-6R) antibody in development for the treatment of patients with rheumatoid arthritis.

On October 28, 2016, Sanofi and Regeneron Pharmaceuticals, Inc. announced the receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Applications (BLA) for sarilumab. The CRL referred to certain deficiencies identified during a routine good manufacturing practice inspection of the manufacturing facility, and did not identify any concerns relating to the safety or efficacy of sarilumab.

Development Status and FDA Approval Process for 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

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