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

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

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.

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