Pfizer has announced that the US Food and Drug Administration (FDA) 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).
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.
If approved by the FDA, tofacitinib would be the first oral Janus kinase (JAK) inhibitor to be a therapeutic option for people living with moderately to severely active UC.
Tofacitinib citrate is a Janus kinase (JAK) inhibitor. Applications for tofacitinib for the treatment of moderately to severely active UC are currently under review by the US FDA and the European Medicines Agency (EMA). It is not currently approved for the treatment of UC.
As the developer of tofacitinib, Pfizer is a leader in JAK science and is committed to enhancing understanding of tofacitinib through robust clinical development programmes in the treatment of immune-mediated inflammatory conditions.