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# Sanofi to Resubmit Sarilumab BLA After Correcting Inspection Issues
- URL: https://www.fdaweb.com/sanofi-to-resubmit-sarilumab-bla-after-correcting-inspection-issues/
- Published: 2017-02-08T12:00:00.000Z
- Updated: 2026-09-14T22:05:15.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5137937

Sanofi says it will resubmit a joint BLA submission with Regeneron Pharmaceuticals for sarilumab, an investigational interleukin-6 receptor antibody for treating adult patients with moderately to severely active rheumatoid arthritis. In October, FDA sent the companies a Complete Response Letter on their BLA, citing certain deficiencies identified during a routine good manufacturing practice inspection of the Sanofi Le Trait facility in France where sarilumab is filled and finished, one of the last steps in the manufacturing process.  
  
Based on a review of Sanofi’s responses to the inspection’s Form 483 letters, as well as proposed corrective actions, FDA has classified the Le Trait facility as “acceptable,” according to the company. The resubmission will follow a successful FDA pre-approval inspection of Le Trait that is expected soon, it adds.