Sanofi grapples with rejection of potential first-in-class orphan drug, faults third-party manufacturing

A snap review didn’t lead to a quick OK for Sanofi’s sutimlimab. A day after the FDA’s supposed decision date on the orphan drug, the French pharma giant said it was handed a rejection.

The complete response letter cites “certain deficiencies identified by the agency during a pre-license inspection of a third-party facility responsible for manufacturing,” Sanofi wrote. Regulators apparently didn’t take any issue with the clinical data or safety.