Sanofi Working To Resolve GMP Issues That Derailed Sarilumab Approval
CEO Olivier Brandicourt says Sanofi's Le Train, France, fill-and-finish facility should be back in FDA’s good graces before the PDUFA goal date for another Sanofi antibody, dupilumab.
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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.
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.
Keeping Track: Immunology In Focus As US FDA Approves Kevzara, New Breakthrough Actemra Use; J&J, Sun Advance Psoriasis Candidates
The latest immunology drug development news and highlights from our FDA Performance Tracker.