Pfizer Xeljanz's Long-term Dosing Raises Safety Concerns In Ulcerative Colitis
US FDA's Gastrointestinal Drugs Advisory Committee will weigh proposed indication as agency appears uncertain whether higher dose can be used as long-term therapy.
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JAK inhibitor, now first oral UC medication in US, is approved for both 5mg and 10mg, but label currently discourages 10mg after 16 weeks.
Postmarket trial looking at reduced doses in UC may be difficult to enroll, Pfizer argues; with approval of expanded indication seeming assured, another postmarket question for Xeljanz could look at impact of herpes zoster vaccine.
US FDA's Gastrointestinal Drugs Advisory Committee says higher dosing regimens can be used despite agency worries about safety with long-term use.