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FDA Accepts Application to Include Ulcerative Colitis in Xeljanz Indications
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The FDA has accepted Pfizer’s supplemental New Drug Application to include the treatment of adults with moderate-to-severe active ulcerative colitis as an indication for Xeljanz.
The Prescription Drug User Fee Act (PDUFA) action date is in March 2018, according to a press release from the manufacturer.
Xeljanz (tofacitinib citrate; Pfizer) is an oral small molecule Janus kinase (JAK) inhibitor currently approved as a second-line treatment in adults with moderate-to-severe active rheumatoid arthritis.
The drug is currently under investigation for ulcerative colitis, and its safety and efficacy has been demonstrated in the three pivotal phase 3 OCTAVE studies, the results of which are included in the sNDA package. These data were recently published in full in the New England Journal of Medicine.
“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,” Michael Corbo, chief development officer, Inflammation and Immunology, Global Product Development, at Pfizer, said in the press 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 (JAK) inhibitor as a therapeutic option for people living with moderately to severely active UC.”
Disclosures: Corbo is employed by Pfizer.