For Ulcerative Colitis, Extended-Release Xeljanz XR Approved by FDA – IBD News Today

Posted: Published on December 19th, 2019

This post was added by Alex Diaz-Granados

The U.S. Food and Drug Administration (FDA) has approvedPfizer's extended-release tablets of Xeljanz XR (tofacitinib) to treat adults with moderately to severely active ulcerative colitis. This approval of 11 mg and 22 mg doses offers these patients the option of taking the medication once, rather than twice, per day. Ulcerative colitis is a chronic inflammatory disease of the colon that can significantly affect a patients quality of life and be emotionally burdensome due to symptoms, flares and complications, Michael Corbo, PhD, chief development officer of inflammation and immunology at Pfizer Global Product Development, said in a press release. 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, Corbo added. Xeljanz was first approved by the FDA for the same indication in 2018 as a 10 mg, twice-daily oral therapy taken for at least eight weeks, after which patients could continue on either 5 mg or 10 mg twice a day. With the newly approved extended-release version, patients can take 22 mg of Xeljanz XR once a day for eight weeks or up to a maximum of 16 weeks as induction therapy. After the induction period, patients may take 11 mg of Xeljanz XR once a day as maintenance treatment. For patients who have a

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For Ulcerative Colitis, Extended-Release Xeljanz XR Approved by FDA - IBD News Today

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