Pfizer's Xeljanz Gains FDA Panel Nod In Psoriatic Arthritis, But Labeling Questions Remain

US advisory committee recommends approval of new indication for the JAK inhibitor but does not want any radiographic progression data in labeling amid questions about effect.

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US FDA approval of Pfizer Inc.'s Xeljanz in psoriatic arthritis does not appear to be in much doubt going forward, but whether radiographic progression information will appear in labeling could be a point of contention.

FDA's Arthritis Advisory Committee on Aug. 3 voted 10-1 to recommend approval of the new indication for Xeljanz (tofacitinib) and...

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