REPORTING FROM an FDA advisory committee meeting
SILVER SPRING, MD. (FRONTLINE MEDICAL NEWS) – Federal advisors to the Food and Drug Administration on March 8 voted unanimously to recommend approval of an additional indication for tofacitinib (Xeljanz), this time for ulcerative colitis.
Members of the Gastrointestinal Drugs Advisory Committee unanimously voted recommend two different dosing regimens: 10 mg twice daily for 16 weeks in patients who have not experienced a therapeutic benefit after 8 weeks of treatment, as well as 10 mg twice daily for patients who have an inadequate or loss of response to TNF blocker therapy.
The committee rejected by a 7-8 vote a recommendation that Pfizer, the drug’s manufacturer, conduct a post-marketing efficacy trial comparing a 10 mg continuous dosing regimen with a 10 mg induction and 5 mg twice daily as maintenance.
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