FDA accepts sNDA for Xeljanz for the treatment of adult patients with active ulcerative colitis

Anticipated Prescription Drug User Fee Act (PDUFA) action date for the sNDA is March 2018 .

Pfizer has announced that the supplemental New Drug Application (sNDA) for Xeljanz (tofacitinib citrate), an investigational oral treatment for adult patients with moderately to severely active ulcerative colitis (UC), has been accepted for filing by the FDA.

The FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) action date in March 2018 for the sNDA.

"Ulcerative colitis is a debilitating inflammatory disease that impacts the physical, emotional and social well-being of nearly one million people in the United States, many of whom are not able to manage their disease," said Michael Corbo, Chief Development Officer, Inflammation & Immunology, Global Product Development, Pfizer Inc. "We look forward to working with the FDA as they consider the application for tofacitinib in UC, with the goal of offering, if approved, the first oral Janus kinase (JAK) inhibitor as a therapeutic option for people living with moderately to severely active UC."

The sNDA submission package included data from three pivotal Phase III studies from the Oral Clinical Trials for tofAcitinib in ulceratiVE colitis global clinical development program (OCTAVE Induction 1, OCTAVE Induction 2 and OCTAVE Sustain) evaluating the safety and efficacy of tofacitinib in patients with moderately to severely active UC, and OCTAVE Open, the open label long-term extension study of tofacitinib in patients who completed or who had treatment failure in OCTAVE Sustain, or who were non-responders in OCTAVE Induction 1 or 2.