FDA rejects Sanofi, Regeneron's experimental rheumatoid arthritis drug sarilumab

Sanofi and Regeneron Pharmaceuticals said Friday that the FDA issued a complete response letter regarding their application for the investigational IL-6R antibody sarilumab for the treatment of adults with moderately to severely active rheumatoid arthritis. According to the companies, the agency cited "certain deficiencies" found during a routine inspection of Sanofi's Le Trait facility in Normandy, France, where sarilumab is filled and finished.

The companies noted that the complete response letter "does not identify any concerns relating to the safety or efficacy of sarilumab." Meanwhile, Sanofi has already submitted and is implementing a corrective action plan, while "working closely with the FDA towards a timely resolution that addresses [the agency's] concerns." Sanofi and Regeneron did not specify when the inspection took place or disclose information about the corrective actions submitted to the FDA.

Sanofi CEO Olivier Brandicourt disclosed during the company's recent third-quarter results presentation that the sarilumab filing, which the FDA had accepted for review earlier this year with a target date of October 30, might be affected by the plant inspection's findings.

Brandicourt also indicated that the issues should be resolved before March 29 of next year, when the FDA is scheduled to render its decision on Sanofi's filing for dupilumab as a potential treatment for adults with inadequately controlled moderate-to-severe atopic dermatitis. Dupilumab is also being co-developed with Regeneron and was accepted for priority review by the US regulator last month. "We have redundant capabilities if necessary," Brandicourt added.

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