Sanofi and Regeneron mull FDA CRL after fill/finish plant hit with 483
According to a Regeneron SEC filing Friday, manufacturing deficiencies were discovered during a routine current Good Manufacturing Practice (cGMP) inspection at a Sanofi facility which conducts fill and finish activities for a number of products, including sarilumab – an interleukin-6 receptor (IL-6R) antibody being co-developed by the two firms.
Sanofi confirmed the issues were observed at its Le Trait facility - located about 100km northwest from Paris, France – during its Q3 conference call Friday, adding that while the issues were not specifically related to sarilumab, they have resulted in the US Food and Drug Administration (FDA) issuing a complete response letter (CRL) to the candidate.
And in an email sent to this publication, a Sanofi spokesperson said the firm received “a Form 483 after an inspection of the Le Trait site by the FDA” with “a number of manufacturing deficiencies identified regarding documentation and processes.”
The spokesperson continued: “Sanofi provided their responses to the Form 483 to the FDA which they believe to be comprehensive and robust. Sanofi’s responses are under review at this time so we are unable to comment any further.”
Sanofi also said the CRL did not identify safety or efficacy concerns relating to sarilumab, and said the two firms remained committed to bringing the potential rheumatoid arthritis (RA) treatment to the US market as soon as possible
“We are confident that our action plan to address the observations cited in the Form 483 will be completed expeditiously,” we were told.
While sarilumab fill/finish occurs at the Le Trait facility, the active pharmaceutical ingredient is manufactured by Regeneron at its site in Rensselaer, New York.
“The FDA has completed a pre-approval inspection of Regeneron’s sarilumab manufacturing facility,” Regeneron said in its filing. “No Form 483 was issued in connection with the inspection.”