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Pfizer’s Xeljanz received FDA approval for extended release dosage form for UC

Pfizer has announced that the US FDA approved Xeljanz XR 11 mg and 22 mg dosage form for patients suffering from moderate to severe ulcerative colitis in patients who have an inadequate response or intolerant to TNF blockers.

Michael Corbo, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development, said: “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.”

The drug is not recommended in combination with TNF inhibitors and potent immunosuppressants such as azathioprine and cyclosporine.

The drug approved for rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. Xeljanz was approved for ulcerative colitis based on two induction trials and one maintenance trial. In the induction trial, the primary endpoint was remission at week 8. The improvement was 10% in the UC-I trial and 13% in the UC-II trial. In the maintenance trial, the primary endpoint was remission at week 52; remission was 23% in patients on 5mg Xeljanz and 30% in patients on 10 mg Xeljanz.


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