FDA ‘Complete Response’ on Sanofi/Regeneron’s Arthritis Therapy

FDA has sent Regeneron Pharmaceuticals and Sanofi a Complete Response Letter on their BLA for sarilumab, an investigational interleukin-6 receptor antibody for treating adult patients with moderately to severely active rheumatoid arthritis. The letter cites 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, the companies say.

Satisfactory resolution of these deficiencies is required before the submission can be approved.  Sanofi submitted a comprehensive corrective action plan to FDA and is implementing the corrective actions specified in that plan, according to the companies. They note that FDA’s letter does not identify any concerns about the therapy’s safety or efficacy.