FDA extends action date for Xeljanz in UC

The US Food and Drug Administration has extended the action date by three months for the supplemental New Drug Application (sNDA) for Xeljanz (tofacitinib), an oral treatment under investigation for adult patients with moderately to severely active ulcerative colitis (UC) by US pharma giant Pfizer (NYSE: PFE).

The FDA determined that additional review time was necessary due to information recently submitted by Pfizer and as such constitutes a major amendment. The FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) date in June 2018.

Pfizer filed the sNDA in July this year, when the FDA has provided an anticipated PDUFA action date in March 2018. News of the delay had little impact on Pfizer’s shares, which in fact edged up 0.99% to $36.58 by close of trading on Tuesday.