The regulator issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for sarilumab, an investigational interleukin-6 receptor (IL-6R) antibody for the treatment of adult patients with moderately to severely active RA.
The FDA identified deficiencies during a routine good manufacturing practice inspection of Sanofi’s facility in Le Trait, France. sarilumab is filled and finished at this facility.
The companies will now have to come up with a satisfactory resolution of the deficiencies before they get an FDA approval of their BLA.
Sanofi said that it is executing the corrective measures specified in the comprehensive corrective action plan it has submitted to the FDA following the latter’s CRL.
While claiming that it is working closely alongside the FDA in bringing a timely resolution to solve the concerns, Sanofi said that the CRL had nothing to do with the safety or efficacy of its drug.
Along with its US partner Regeneron, Sanofi said that it is still committed to sarilumab development and would soon provide the therapy to rheumatoid arthritis patients in the US.
Once approved, sarilumab is said to be commercialized by Regeneron and Sanofi’s specialty care global business unit Sanofi Genzyme.