Additional review time requested for ulcerative colitis drug
Pfizer Inc. said Tuesday the Food and Drug Administration has extended the action date by three months for the supplemental New Drug Application (sNDA) for XELJANZ®(tofacitinib).
The oral medication is for adults with moderately to severely active ulcerative colitis. It's estimated that between 10% and 30% of those with ulcerative colitis are over age 60.
If approved, tofacitinib would be the first oral Janus kinase inhibitor to be a therapeutic option for those with this type of colitis.