FDA/CDC

Xeljanz: FDA panel recommends ulcerative colitis indication


 

REPORTING FROM AN FDA ADVISORY COMMITTEE MEETING

– 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 to 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, based on the results of several phase 3 clinical trials.

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The committee rejected by a 7-8 vote a recommendation that Pfizer, the drug’s manufacturer, conduct a postmarketing efficacy trial comparing a 10-mg continuous dosing regimen with a 10-mg induction and 5 mg twice daily as maintenance.

The recommended ulcerative colitis (UC) indication was based on the OCTAVE trials (N Engl J Med 2017;376:1723-36), including a phase 2 study, two identical phase 3 induction trials (OCTAVE Induction 1 and OCTAVE Induction 2), a 53-week, phase 3 maintenance trial (OCTAVE Sustain), and an open-label extension study.

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