US FDA accepts Pfizer’s sNDA for Xeljanz to treat ulcerative colitis

The US Food and Drug Administration (FDA) has accepted for filing Pfizer’s supplemental New Drug Application (sNDA) for Xeljanz (tofacitinib citrate), an investigational oral solution to treat adult patients affected with moderately to severely active ulcerative colitis (UC).

For the sNDA, FDA has issued an anticipated Prescription Drug User Fee Act (PDUFA) action date in March 2018.

UC is a chronic bowel disease with various symptoms such as chronic diarrhoea with blood and mucus, abdominal pain and cramping and fever.

The exact cause of UC is yet to be determined and despite receiving treatment, many patients continue to experience symptoms.

Pfizer global product development inflammation and immunology chief development officer Michael Corbo said: "Ulcerative colitis is a debilitating inflammatory disease that impacts the physical, emotional and social well-being of nearly one million people in the US, many of whom are not able to manage their disease.

"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."

The sNDA submission package comprised three pivotal Phase III studies from the Oral Clinical Trials for tofacitinib in ulcerative colitis global clinical development programme (OCTAVE Induction 1, OCTAVE Induction 2 and OCTAVE Sustain).

The studies analysed the safety and efficacy of tofacitinib in patients suffering from moderately to severely active UC.

The detailed results of the OCTAVE Induction 1, OCTAVE Induction 2 and OCTAVE Sustain were published in The New England Journal of Medicine last May.

Tofacitinib citrate is a Janus kinase (JAK) inhibitor yet to receive approval to treat UC in adult patients.

Pfizer made a note to advance the studies of JAK inhibition and improve the understanding of tofacitinib through robust clinical development programmes.