Pfizer Tofacitinib’s Fate May Rest On Radiographic Data

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.

This would be the first JAK inhibitor for RA, with the requested indication being for treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs. Another JAK inhibitor, Incyte Corp

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