The US Food and Drug Administration (FDA) has given its seal of approval to Pfizer’s Xeljanz (tofacitinib), a JAK inhibitor that could strengthen Pfizer’s stance in the inflammatory bowel disease (IBD) market.
The twice-daily, orally administered drug is set to treat adult patients with moderately-severely active ulcerative colitis (UC), an often-debilitating disease that affects approximately 907,000 people in the US alone.
Michael Goettler, global president, inflammation and immunology, Pfizer, 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.”
The green light was given to Xeljanz based on positive phase III data from the OCTAVE trials, which produced induction data showing a statistically significant, greater proportion of UC patients in remission at week 8 compared to those on placebo.
A similar result presented itself throughout the maintenance study, during which, it was reported that a statistically significant amount of patients were in remission at week 52 compared to those on placebo.
Xeljanz is already doing well in the arthritis disease area – after picking up US approvals in rheumatoid arthritis and psoriatic arthritis – where the drug is the first and only JAK inhibitor approved by the FDA.
Continuing this trend, Xeljanz is also the first and only JAK inhibitor approved in the US to treat UC, and an approval in the IBD therapy area for this particular class of drugs bolsters Pfizer’s position in the market, one that is currently dominated by TNF inhibitors, according to a report by ReportBuyer.
That report also predicted that TNF inhibitors are set to gain more of a market share by the end of 2025, however Xeljanz does have the advantage of being administered orally compared to other FDA-approved treatments for UC, which must be administered through an intravenous infusion or subcutaneous injection.