Production & Manufacturing
Process & Production

FDA committee votes in favor of Pfizer's Xeljanz for ulcerative colitis

PBR Staff Writer Published 09 March 2018

Pfizer has received a positive response from the Gastrointestinal Drugs Advisory Committee (GIDAC) of the US Food and Drug Administration (FDA) for its supplemental new drug application (sNDA) on Xeljanz (tofacitinib) to treat adult patients with moderately to severely active ulcerative colitis (UC).

Tofacitinib is a Janus kinase (JAK) inhibitor, which is yet to secure approval for the treatment of UC.

The FDA and the European Medicines Agency (EMA) are currently reviewing the applications for ofacitinib to treat moderately to severely active UC.

The 15-member FDA committee has voted unanimously in favor of the extension of the use of tofacitinib 10mg twice-daily (BID) from eight to 16 weeks of induction in adult patients who have not achieved adequate therapeutic benefit by week eight.

The committee has also voted unanimously in favor of 10mg BID as continuous maintenance treatment for adult patients with an inadequate response, loss of response or intolerance to tumor necrosis factor (TNF) blocker therapy.

Pfizer Global Product Development’s inflammation and immunology chief development officer Michael Corbo said: “Today’s discussion underscored the significant unmet need that exists for people living with ulcerative colitis, a disease that is often debilitating and difficult to control. We are encouraged about the positive outcome of today’s GIDAC meeting.

“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. We look forward to working with the FDA as it completes the review of our pending application.”

Xeljanz or Xeljanz XR is already approved for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs).

It can be used as monotherapy or in combination with methotrexate or other (DMARDs).

UC is a chronic and debilitating inflammatory bowel disease, and its symptoms include chronic diarrhea with blood and mucus, abdominal pain and cramping, and weight loss.