After a three-month delay, the FDA’s Gastrointestinal Drug Advisory Committee (GIDAC) voted on March 8th to recommend approval to extend Xeljanz’s indication to include ulcerative colitis (UC)1

Pfizer’s Xeljanz is already FDA-approved for the treatment of rheumatoid arthritis (RA) and psoriatic arthritis (PsA) as either a 5mg BID dose or a once-daily dose of Xeljanz XR (11mg), an extended-release formulation. However, the supplemental new drug application (sNDA) for Xeljanz in UC seeks approval for a 10mg BID induction dose of Xeljanz in UC patients followed by either a 5mg BID maintenance dose or a 10mg BID dose in UC patients with an inadequate response, loss of response, or intolerance to TNFα inhibitors. Rather than focusing specifically on approval of Xeljanz for UC, the focus of the March 8th GIDAC meeting appears to have been driven by concerns around the higher 10mg dose, which had previously encountered difficulties with the FDA when Pfizer sought approval for Xeljanz in RA (ultimately approved at 5mg only)2 and Psoriasis (approval was denied and ultimately, development terminated)3.

All three questions that the GIDAC voted on during this meeting were related to usage of the higher 10mg BID Xeljanz dose:

  • Extension of the use of tofacitinib 10mg BID from 8 to 16 weeks of induction in adult patients who have not achieved adequate therapeutic benefit by Week 8
  • Use of 10mg BID as continuous maintenance treatment for adult patients with an inadequate response, loss of response, or intolerance to TNF blocker therapy
  • Conducting a post-marketing efficacy study comparing a tofacitinib 10mg BID continuous dosing regimen to a regimen of tofacitinib 10 mg BID induction and 5mg BID as maintenance in this patient population


While the GIDAC voted unanimously (15-0) in favor of questions 1 and 2, there was a close vote against conducting a post-marketing efficacy study comparing the two maintenance dosing options (8-7).

The strength of the votes in favor of permitting the 10mg dose of Xeljanz (as part of an extended induction regimen or as a maintenance therapy in patients where necessary) suggests that, despite previous FDA concerns with the higher 10mg strength, the drug—in both a 5 and 10mg BID dose—is likely to win approval for UC by the scheduled PDUFA date at the end of June. As such, Xeljanz is poised to become the first oral agent approved for moderate-to-severe UC and the first member of the JAK inhibitor class to win approval in a GI indication.

We have previously discussed the substantial opportunity for the JAK inhibitors (including Xeljanz) in IBD: here.

The Decision Resources Group Immune and Inflammatory team will be conducting a launch-tracking study following the expected approval of Xeljanz for UC, conducting surveys at one-month, six-months, and one-year post-launch.

Ulcerative Colitis | Emerging Therapies | Xeljanz (Ulcerative Colitis) | US

This study will complement our ongoing launch-tracking study of Xeljanz for PsA, the first wave of which will publish at the end of March and our launch-tracking study of Xeljanz for RA which we conducted between 2012 and 2014.

Psoriatic Arthritis | Emerging Therapies | Xeljanz (Psoriatic Arthritis) | US

Rheumatoid Arthritis | Emerging Therapies | Xeljanz (Rheumatoid Arthritis) | US


For questions on these launch-tracking series or other DRG content, please contact:


  1. Accessed March 16, 2018
  2. Accessed March 16, 2018
  3. Accessed March 16, 2018

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