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.
Tofacitinib — sold under the brand name Xeljanz — is a Janus kinase (JAK) inhibitor approved by the FDA to treat moderate to severe rheumatoid arthritis (RA), and adults with active psoriatic arthritis (PsA). Currently, both FDA and the European Medicines Agency (EMA) are reviewing Xeljanz for its potential to treat UC.
The GIDAC voted 8-7 against a third question related to a potential post-marketing study in these patients. That study would have assessed and compared the efficacy of a continuous regimen of Xeljanz, 10 mg doses twice daily, against a two-dose step with a 10 mg of twice daily induction phase, followed by a maintenance phase of 5 mg Xeljanz twice a day.
“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,” Corbo said. “We look forward to working with the FDA as it completes the review of our pending application.”
GIDAC gives recommendations to the regulatory agency, but the FDA makes a final decision on Pfizer’s request to approve Xeljanz to treat adults with UC. That decision is expected in June 2018.