FDA Advisory Panel Favors Extended Use of Xeljanz by Certain Ulcerative Colitis Patients

FDA Advisory Panel Favors Extended Use of Xeljanz by Certain Ulcerative Colitis Patients
An advisory arm of the U.S. Food and Drug Administration (FDA) gave two positive recommendations to Pfizer’s supplemental New Drug Application, seeking FDA approval for extended use of Xeljanz (tofacitinib) by certain adult patients with moderately to severely active ulcerative colitis (UC). The Gastrointestinal Drugs Advisory Committee (GIDAC) voted unanimously in favor (15–0) to extend the induction dosage period of Xeljanz (10 mg twice a day) — from eight weeks to 16 weeks — for UC patients who have failed to respond adequately to the therapy after eight weeks. Committee members also voted unanimously (15–0) in favor of continuous treatment with Xeljanz, again at 10 mg doses twice daily, for adults who have had a poor response, a loss of response, or are intolerant to anti-tumor necrosis factor (TNF) therapy. “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,” Michael Corbo, chief development officer, Inflammation & Immunology, Pfizer Global Product Development said in a press release
Subscribe or to access all post and page content.

Leave a Comment

Your email address will not be published. Required fields are marked *