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Sanofi Stunned As FDA Says No To CAD Drug Sutimlimab

Deficiencies At Third-Party Manufacturing Facility

 
• By Kevin Grogan

The French major's hopes for launching its rare blood disorder drug sutimlimab soon have been scuppered by a complete response letter from the FDA after inspecting a third-party facility responsible for making the first-in-class therapy.

sanofi at night
Dark day for Sanofi's sutimlimab • Source: Shutterstock

Sanofi has suffered a surprising regulatory setback after being hit by a rejection from the US Food and Administration for sutimlimab, its treatment of hemolysis in adults with cold agglutinin disease (CAD).

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