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
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