FDA Accepts Supplemental New Drug Application for Tofacitinib Citrate to Treat Ulcerative Colitis

The FDA recently accepted a supplemental New Drug Application for tofacitinib citrate (Xeljanz) to treat adult patients with moderate-to-severe active ulcerative colitis (UC).

The submission package included data from the pivotal phase 3 studies OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain, which evaluated the safety and efficacy of tofacitinib citrate in patients with moderate-to-severe active UC, according to a press release.

Data were also included from the open-label, long-term extension study OCTAVE Open, which examined patients who completed or who had treatment failure in OCTAVE Sustain, or who were nonresponders to OCTAVE Induction 1 or 2.

“Ulcerative colitis is a debilitating inflammatory disease that impacts the physical, emotional, and social well-being of nearly 1 million people in the United States, many of whom are not able to manage their disease,” Michael Corbo, chief development officer, Inflammation & Immunology, Global Product Development, Pfizer Inc, said in a release. “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 inhibitor as a therapeutic option for people living with moderately to severely active UC.”

Tofacitinib citrate is a JAK inhibitor approved to treat rheumatoid arthritis (RA). It is designed to act on the JAK pathway by working inside the cell to disrupt a signaling pathway believed to play a role in inflammation associated with moderate-to-severe active RA.

The anticipated Prescription Drug User Fee Act action date for supplemental New Drug Application is March 2018.