Pfizer has secured the US Food and Drug Administration (FDA) approval for its XELJANZ XR (tofacitinib) for moderately to severely active ulcerative colitis (UC) in adult patients.

The regulatory approval indicated XELJANZ XR extended-release 11mg and 22mg tablets as once-daily treatment for treating adult patients with moderately to severely active ulcerative colitis (UC), following intolerance to TNF blockers.

Pfizer global product development inflammation and immunology chief development officer Michael Corbo said: “Ulcerative colitis is a chronic inflammatory disease of the colon that can significantly affect a patient’s quality of life and be emotionally burdensome due to symptoms, flares and complications.

“We are pleased to now offer patients with moderately to severely active ulcerative colitis and their healthcare providers a convenient once-daily dosing option with XELJANZ.”

Patients treated with XELJANZ XR are at risk for developing critical infections

XELJANZ is approved in the US for adult patients in three indications including moderately to severely active rheumatoid arthritis (RA), active psoriatic arthritis (PsA), following disease-modifying antirheumatic drug (DMARD) failure and moderately to severely active ulcerative colitis (UC), following the failure of tumour necrosis factor inhibitor (TNFi).

Pfizer said that its XELJANZ has been subjected to more than 50 clinical trials across the world, of which more than 20 trials are in RA patients. The drug has been prescribed to more than 208,000 adult patients, in the last seven years.

In addition, the company claimed that it will advance the research on JAK inhibition and enhance the understanding of tofacitinib, through clinical development programs in the treatment of immune-mediated inflammatory conditions.

The company said that the patients treated with XELJANZ XR are at increased risk for developing critical infections, which may potentially lead to hospitalization or death. The patients who developed infections were advised to take concomitant immunosuppressants like methotrexate or corticosteroids.

Furthermore, the drug use has reported infections including active tuberculosis, invasive fungal infections (cryptococcosis and pneumocystosis), along with bacterial, viral, and other infections by opportunistic pathogens.