Tuesday, November 2, 2021

Sanofi’s hopes for rare blood disease candidate sutimlimab on hold after FDA blasts 3rd-party manufacturer

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. 

RELATED: Sanofi nabs speedy review of sutimlimab, aiming for a November approval

In May, the FDA accepted Sanofi’s sutimlimab application under priority review based on the strength of the drug’s pivotal phase 3 data, Sanofi believed. Those results, unveiled in late 2019, showed 13 of the 24 patients treated with sutimlimab after 26 weeks met the study’s primary endpoint, a composite assessment that looked at hemoglobin and freedom from transfusions.

Close to two-thirds of participants met the hemoglobin part of the endpoint, indicating they either experienced a 2 g/dL increase from baseline or ended the study with 12 g/dL or higher, a level that is at the bottom of the normal range for women and just below it for men. More than two-thirds of the subjects were free from transfusions from week five onward.

The FDA’s letter did not target sutimlimab’s clinical findings or safety, Sanofi noted in a release.

RELATED: Nabriva hit with another FDA setback with complete response letter for antibiotic Contepo

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