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Pfizer Tofacitinib’s Fate May Rest On Radiographic Data

This article was originally published in The Pink Sheet Daily

Executive Summary

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.

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Tofacitinib Delay May Give FDA Time To Look At New Radiographic Data

FDA has extended the review deadline to look over requested data on tofacitinib, but Pfizer also is interested in turning over an interim analysis of the ORAL Start study, which provides radiographic evidence of tofacitinib’s structural benefit in rheumatoid arthritis, a weak point in the NDA.

Tofacitinib Delay May Give FDA Time To Look At New Radiographic Data

FDA has extended the review deadline to look over requested data on tofacitinib, but Pfizer is also interested in turning over an interim analysis of the ORAL Start study, which provides radiographic evidence of tofacitinib’s structural benefit in rheumatoid arthritis, a weak point in the NDA.

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