When a new drug goes in front of the FDA for consideration, a lot of moving pieces must be in place for a successful review—manufacturing standards included. That didn’t happen for Sanofi, which is pressing pause on a rare disease candidate after the FDA found issues at a contract manufacturer’s plant.
The FDA blasted a third-party manufacturer of Sanofi’s rare blood disease drug sutimlimab in a complete response letter, citing “certain deficiencies” at the contractor’s site, the French drugmaker said Friday.
A Sanofi spokeswoman declined to specify who the manufacturer cited in the FDA’s letter was or what the nature of the deficiencies were.
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With its application on hold, Sanofi said it would work with its manufacturer and the FDA to resolve the issues in a “timely manner.” The drugmaker didn’t say how quickly it expected to turn around a new application.
The untimely feedback from the FDA dims C1 inhibitor sutimlimab’s chances in cold agglutinin disease (CAD), a rare blood disease characterized by anemia, fatigue and other symptoms.
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