The FDA has approved Pfizer's Xeljanz (tofacitinib) for the treatment of moderately to severely active ulcerative colitis.
The oral therapy is the first and only Janus kinase (JAK) inhibitor approved in the US for this patient population.
“What works for one ulcerative colitis patient may not work for another and some struggle with ongoing symptoms. That is why it is so critical that our patients have different treatment options available to them,” said Michael Osso, President & CEO of the Crohn’s & Colitis Foundation.
This approval was based on data from three pivotal Phase 3 studies from the OCTAVE global clinical development, which all met their respective primary endpoints, showing a statistically significant, greater proportion of patients in remission at week 8 in the induction studies and in remission at week 52 in the maintenance study in patients with moderately to severely active UC treated with tofacitinib compared to placebo
UC is a chronic and often debilitating inflammatory bowel disease that affects approximately 907,000 people in the US. Symptoms of UC can include chronic diarrhea with blood and mucus, abdominal pain and cramping, and weight loss. UC can have a significant effect on work, family and social activities.
Xeljanz is also approaved by the FDA for is the first and only inhibitor approved by the FDA for adult patients with moderately to severely active rheumatoid arthritis (RA) and active psoriatic arthritis (PsA).