FDA/CDC

Xeljanz: FDA panel recommends ulcerative colitis indication


 

REPORTING FROM AN FDA ADVISORY COMMITTEE MEETING


“I think the safety concerns, though, they are dose dependent, the difference between the 5 [mg] and 10 [mg] were not large,” according to Dr. Pardi. “Several of these are mitigatable by dermatologic exam or, hopefully, a vaccine.”

Several of the advisory committee members submitted conflict of interest waivers. Chair and vice chair Jean-Pierre Raufman, MD, and Darrell Pardi, MD, disclosed funding from competing pharmaceutical manufacturers.

*This article was updated on March 12, 2018.

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