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.
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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.
The Swiss giant's blockbuster is the first non-steroid therapy approved in Europe for giant cell arteritis and the first major advance in treatment for over 50 years.
Genentech's interleukin-6 inhibitor got bonus approval based on data from development programs for Novartis' and Kite's chimeric antigen receptor T-cell therapies; CAR-T developers allowed FDA to access the Actemra-related data in their applications and conduct its own pooled analysis.