Sanofi/Regenerin Resubmit BLA for Sarilimab

Sanofi and Regeneron Pharmaceuticals have resubmitted their BLA for sarilumab, an investigational interleukin-6 receptor antibody for treating adult patients with moderately to severely active rheumatoid arthritis. In 10/2016, 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, as well as proposed corrective actions, FDA has classified the Le Trait facility as “acceptable,” according to the company. The resubmission presumably follows a successful FDA pre-approval inspection of Le Trait. The agency has classified the submission as a Class I response with a two-month review timeline and a user fee target review date of 5/22.