FDA accepts sNDA for Xeljanz in ulcerative colitis

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 US Food and Drug Administration.

The FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) action date in March 2018 for the sNDA, says the drug’s maker, US pharma giant Pfizer (NYSE: PFE).

The drug is already approved in more than 80 countries for rheumatoid arthritis (RA) and generated sales of $927 million in 2016. However, first-quarter sales of $250 million missed Wall Street expectations of $288 million. The global market for UC treatments is expected to reach around $4 billion in the next few years.

“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 and immunology, global product development, Pfizer. “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.”