FDA declines approval for Sanofi drug over manufacturing issues

The FDA has kicked back an approval application from Sanofi for its drug, sutimlimab.

On Friday, the company announced that the agency cited “certain deficiencies” related to its contract manufacturer — but did not specify who the third-party is or what specific issues were raised by the FDA.

Sanofi filed for a Biologics License Application (BLA) for sutimlimab, a monoclonal antibody, for the treatment of hemolysis in patients with cold agglutinin disease, a rare blood disorder. The first-in-class therapy was given a priority review status by the FDA in May. 

In its rejection, the agency noted that there were no clinical or safety issues related to sutimlimab in the BLA. Sanofi will now have to rectify the manufacturing issues before it can resubmit its application to the FDA.

Read the press release.