Regulatory Affairs

Pfizer’s Xeljanz gets FDA approval for ulcerative colitis

PBR Staff Writer Published 31 May 2018

Pfizer’s Janus kinase (JAK) inhibitor Xeljanz (tofacitinib) has been approved by the US Food and Drug Administration (FDA) to treat adult patients with moderately to severely active ulcerative colitis.

The approval is for the drug to be taken orally twice daily (BID) in 10mg dosage for at least eight weeks, followed by 5mg BID or 10mg BID of the drug.

Xeljanz’s latest approval makes it the first oral medication for chronic use in the indication.

The other treatments approved by the FDA for moderately to severely active ulcerative colitis are to be given via an intravenous infusion or subcutaneous injection.

Ulcerative colitis is a chronic, inflammatory bowel condition that affects the colon with patients suffering from it prone to recurrent flares of abdominal pain and bloody diarrhea.

FDA center for drug evaluation and research office of drug evaluation III director Julie Beitz said: “New treatments are needed for patients with moderately to severely active ulcerative colitis.

“Today’s approval provides an alternative therapy for a debilitating disease with limited treatment options.”

Xeljanz’s approval was driven by the findings of three phase 3 trials - Octave Induction 1, Octave Induction 2 and Octave Sustain along with an ongoing long-term extension study called Octave Open.

The phase 3 trials were held in patients with moderately to severely active ulcerative colitis to evaluate Xeljanz in comparison to placebo.

All the three late-stage trials met their respective primary endpoints. Xeljanz was able to demonstrate a statistically significant, greater percentage of patients in remission at week 8 in the induction studies and in remission at week 52 in the maintenance study.

Pfizer inflammation and immunology global president Michael Goettler said: “Ulcerative colitis is a chronic inflammatory bowel disease that can significantly impact the lives of patients and has limited therapeutic options available.

“With the FDA approval of Xeljanz, adults living with moderately to severely active UC now have an oral option that may help achieve and maintain steroid-free remission.”

Image: Pfizer World Headquarters in Manhattan, New York pictured in 2016. Photo: courtesy of Coolcaesar/