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Kevzara: Sanofi Caught In Middle Of US FDA Debate On Data Analysis

Executive Summary

Agency staff concluded that sarilumab demonstrated less radiographic progression of structural damage in a 52-week trial but disagreed over the statistical method that should be used to show the data in labeling. CDER Director Woodcock made the final call, choosing the method preferred by sponsor Sanofi and long used for other rheumatoid arthritis treatments.

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