Kevzara: Sanofi Caught In Middle Of US FDA Debate On Data Analysis
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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Chronicle of the development and FDA review of Sanofi and Regeneron's interleukin-6 receptor antagonist sarilumab.
Lipid increases in sarilumab's clinical program spurred consideration of a cardiovascular outcomes trial postmarketing requirement akin to that conducted for Genentech's Actemra. However, Medical Policy Council's new subcommittee recommended against requiring a study, citing feasibility concerns.
In memo to then-Commissioner Califf during review of Sarepta's Exondys 51, Jenkins wrote that he was concerned about leaving OND in hands of CDER director upon his retirement.