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Pfizer Tofacitinib’s Fate May Rest On Radiographic Data

 
• By Martin Berman-Gorvine

The marketability and even the approvability of the first-in-class JAK inhibitor for treatment of rheumatoid arthritis may hinge on whether it can be shown to offer patients a structural benefit. FDA briefing documents for the May 9 advisory committee review show issues with those findings.

FDA’s Arthritis Advisory Committee will be tasked with determining whether a novel treatment for rheumatoid arthritis can be approved despite inconclusive radiographic data, when it meets May 9 to review Pfizer Inc.’s Janus kinase inhibitor tofacitinib.

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