Pfizer Says FDA Panel Votes In Favor of Expanding Use of Xeljanz
By Aisha Al-Muslim
Pfizer Inc. (PFE) said Thursday that a Food and Drug Administration panel voted in favor of expanding the use of its arthritis treatment drug Xeljanz.
The FDA's Gastrointestinal Drugs Advisory Committee discussed Pfizer's supplemental new drug application for Xeljanz (tofacitinib), which is currently under review by the FDA, to treat patients with moderately to severely active ulcerative colitis.
Xeljanz isn't currently approved by the FDA to treat ulcerative colitis, an inflammatory bowel disease that causes long-lasting inflammation and ulcers in the digestive tract. Symptoms can include chronic diarrhea with blood and mucus, abdominal pain and cramping, and weight loss.
The committee voted unanimously (15-0) on two dosing questions related to the use of the 10mg twice-daily (BID) dose beyond the eight-week induction period, the company said in a press release. The committee voted in favor of extending the use from eight to 16 weeks of induction in adult patients who have not achieved adequate therapeutic benefit by week eight. It also voted in favor of it as continuous maintenance treatment for adult patients with an inadequate response, loss of response or intolerance to tumor necrosis factor (TNF) blocker therapy.
However, the committee voted 8-7 against conducting a post-marketing efficacy study comparing a tofacitinib 10mg BID continuous dosing regimen versus a regimen of tofacitinib 10mg BID induction and 5mg BID as maintenance in this patient population.
The committee provides recommendations to the FDA, but the recommendations are nonbinding. The FDA's decision on whether or not to approve tofacitinib for ulcerative colitis is expected in June.
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, the company said.
Write to Aisha Al-Muslim at email@example.com
(END) Dow Jones Newswires
March 08, 2018 18:23 ET (23:23 GMT)Copyright (c) 2018 Dow Jones & Company, Inc.