Xeljanz Gets FDA Committee Nod for Ulcerative Colitis Indication

The supplemental NDA is currently under review by the FDA
The supplemental NDA is currently under review by the FDA

Pfizer announced that the Food and Drug Administration (FDA)'s Gastrointestinal Drugs Advisory Committee (GIDAC) voted favorably in support of Xeljanz (tofacitinib) for the treatment of adults with moderately to severely active ulcerative colitis (UC).

Xeljanz, a Janus kinase (JAK) inhibitor, is already approved to treat adults with moderately to severely active rheumatoid arthritis and adults with active psoriatic arthritis.

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The sNDA included a proposed dosing regimen of tofacitinib 10mg twice daily for 8 weeks of induction, followed by tofacitinib 5mg twice daily for maintenance for patients with moderate to severely active UC. The Committee voted 15-0 in favor of extending the use of tofacitinib 10mg twice daily from 8 to 16 weeks of induction in adults who have not achieved adequate therapeutic benefit by Week 8. The Committee also voted 15-0 in favor of the 10mg twice daily dose for continuous maintenance treatment for adults with inadequate response, loss of response or intolerance to tumor necrosis factor (TNF) blocker therapy. 

In addition, the Committee voted 8-7 against conducting a post-marketing efficacy study comparing tofacitinib 10mg twice daily continuous dosing regimen vs tofacitinib 10mg twice daily induction + 5mg twice daily maintenance for these patients.

The GIDAC recommendations are provided to the FDA but they are not binding. The FDA has set a target PDUFA action date of June 2018.

"If approved, tofacitinib will be the first Janus kinase inhibitor and the first oral therapy for adults living with moderately to severely active ulcerative colitis," said Michael Corbo, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development.

For more information call (800) 438-1985 or visit Pfizer.com.