Pfizer's Xeljanz Approval In UC Includes Postmarket Study On Long-Term Effects

JAK inhibitor, now first oral UC medication in US, is approved for both 5mg and 10mg, but label currently discourages 10mg after 16 weeks.

FDA Approved typed words on a vintage typewriter

Postmarketing trials may help alleviate the US FDA's concerns about the long-term use of a high dose of Pfizer Inc.'s Xeljanz (tofacitinib) in ulcerative colitis (UC).

FDA's May 30 approval of the product in UC made the JAK inhibitor the first oral therapy marketed for the indication in the US. EMA's Committee for Medicinal Products...

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