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Xeljanz's UC Indication On Track With Higher Doses After Unanimous Advisory Committee Votes

 
• By Derrick Gingery

US FDA's Gastrointestinal Drugs Advisory Committee says higher dosing regimens can be used despite agency worries about safety with long-term use.

FDA Advisory Committee Feature image

The US FDA's concerns about the long-term safety of a larger dose of Pfizer Inc.'s Xeljanz were set aside by the Gastrointestinal Drugs Advisory Committee in favor of providing another treatment option for desperate patients.

Committee members voted unanimously March 8 to recommend that 10 mg post-induction phase dosing regimens of Xeljanz (tofacitinib) be included...

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