Tofacitinib XR to treat ulcerative colitisFebruary 6, 2020
Pfizer said tofacitinib (Xeljanz XR) extended-release 11 mg and 22 mg tablets was granted approval by USFDA for the once-daily treatment of ulcerative colitis (UC).
Tofacitinib is indicated for the treatment of adult patients with moderately to severely active UC, who have had an inadequate response or who are intolerant to TNF blockers.
Tofacitinib is approved in the US for adult patients in three indications: moderately to severely active rheumatoid arthritis (RA) after methotrexate failure, active psoriatic arthritis (PsA) after disease-modifying antirheumatic drug (DMARD) failure and moderately to severely active ulcerative colitis (UC) after tumour necrosis factor inhibitor (TNFi) failure.
The drug has been studied in more than 50 clinical trials worldwide, including more than 20 trials in RA patients, and prescribed to over 208,000 adult patients worldwide in the last seven years.
As the developer of tofacitinib, Pfizer is committed to advancing the science of JAK inhibition and enhancing understanding of tofacitinib through robust clinical development programmes in the treatment of immune-mediated inflammatory conditions.