The U.S. Food and Drug Administration expanded the approved usage of Pfizer Inc.'s arthritis drug Xeljanz, making it the first oral therapy for treating a certain bowel disease.
Xeljanz is now approved to treat moderately to severely ulcerative colitis, a chronic inflammatory bowel disease affecting the colon, or large intestine.
The regulator noted that all the other therapies for the chronic treatment of the disease are given through an intravenous infusion or subcutaneous injection.
The efficacy of Xeljanz to treat moderately to severely active ulcerative colitis was demonstrated in three clinical trials, including two eight-week placebo-controlled trials showing that 10 milligrams of Xeljanz given twice daily induces remission in 17% to 18% of patients by week eight.
In a placebo-controlled trial among patients who achieved a clinical response by week eight, Xeljanz, at a dosage of 5 milligrams or 10 milligrams given twice daily, was effective in inducing remission by week 52 in 34% and 41% of patients, respectively. Out of patients who achieved remission after eight weeks of treatment, 35% and 47% achieved sustained corticosteroid-free remission when treated with 5 milligrams and 10 milligrams, respectively.
Xeljanz also has a boxed warning for adverse side effects such as serious infections and malignancy. Patients treated with Xeljanz are at increased risk for developing serious infections that may lead to hospitalization or death. Lymphoma and other malignancies have been observed in patients treated with the drug.
The drug's common side effects include diarrhea, higher cholesterol levels, headache, shingles, increased blood creatine phosphokinase, common cold, rash and upper respiratory tract infection.
In December 2017, the FDA delayed the approval date for expanding Xeljanz's indication in ulcerative colitis by three months from March.
Xeljanz, or tofacitinib, is already approved in the U.S. for treating rheumatoid arthritis and psoriatic arthritis.
