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# FDA Panel Backs Expanded Use of Pfizer’s Xeljanz
- URL: https://www.fdaweb.com/fda-panel-backs-expanded-use-of-pfizers-xeljanz/
- Published: 2018-03-09T12:00:00.000Z
- Updated: 2026-09-14T23:28:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140950

FDA’s Gastrointestinal Drugs Advisory Committee has voted unanimously (15-0) to support approval of a Pfizer supplemental NDA for Xeljanz (tofacitinib) to treat adults with moderately to severely active ulcerative colitis. The positive vote follow***s*** a data presentation that showed that after eights weeks of treatment a significantly greater proportion of patients receiving tofacitinib were in remission compared to those taking a placebo. Trial data also showed that a significantly greater number of patients in the tofacitinib arm achieved the secondary endpoint of mucosal healing at week eight compared to placebo. Xeljanz is currently approved for treating rheumatoid arthritis and psoriatic arthritis, with sales of about $1.4 billion.