FDA approves oral treatment for ulcerative colitis

Pfizer’s janus kinase (JAK) inhibitor drug Xeljanz (tofacitinib) has received expanded approval from the FDA for adults with moderately-to-severely-active ulcerative colitis.

It is the first oral medication approved for chronic use in this indication, as other treatments must be administered through intravenous infusion or subcutaneous injection.

Pfizer has been working to extend the uses for the inflammatory diseases drug.

Ulcerative colitis is a chronic, inflammatory bowel disease affecting the colon. Patients experience recurrent flares of abdominal pain and bloody diarrhoea. Other symptoms include fatigue, weight loss and fever. More than 900,000 patients are affected in the US and there is currently no cure.

The efficacy of Xeljanz was demonstrated in three controlled clinical trials. These included two eight-week, placebo-controlled trials that demonstrated that 10 mg of Xeljanz given twice daily induced remission in 17-18% of patients by week eight.

In a placebo-controlled trial among patients who achieved a clinical response by week eight, Xeljanz, at a 5 mg or 10 mg dose given twice daily, was effective in inducing remission by week 52 in 34% and 41% of patients, respectively. Among patients who achieved remission after 8 weeks of treatment, 35% and 47% achieved sustained corticosteroid-free remission when treated with 5 mg and 10 mg, respectively.

The safety of Xeljanz in chronic use for ulcerative colitis was studied in the 52-week placebo- controlled trial.

The most common adverse events were diarrhoea, elevated cholesterol levels, headache, herpes zoster (shingles), increased blood creatine phosphokinase, nasopharyngitis (common cold), rash and upper respiratory tract infection.

Xeljanz has a boxed warning for serious infections and malignancy.

Use of the drug in combination with biological therapies for ulcerative colitis or with potent immunosuppressants, such as azathioprine and cyclosporine, is not recommended.

Xeljanz was approved for rheumatoid arthritis in 2012 and for psoriatic arthritis in 2017.

Pfizer eyes gastro use for Xeljanz after thumbs-up from FDA advisers