FDA Approves Pfizer’s Xeljanz, an Oral Twice Daily Treatment for Adults with Moderate to Severe Ulcerative Colitis

FDA Approves Pfizer’s Xeljanz, an Oral Twice Daily Treatment for Adults with Moderate to Severe Ulcerative Colitis
The U.S. Food and Drug Administration (FDA) has approved the oral therapy Xeljanz (tofacitinib), by Pfizer, to treat adults with moderately to severely active ulcerative colitis (UC), the company announced. The treatment regimen calls for taking Xeljanz twice a day at 10 mg for at least eight weeks, after which patients can continue on the twice-daily therapy, either at 5 mg or 10 mg. “The FDA approval of XELJANZ is positive news for the ulcerative colitis community, a patient population that can often encounter frequent and debilitating disruptions to their daily lives,” William J. Sandborn, MD, Chief, Division of Gastroenterology at the University of California San Diego School of Medicine and investigator in the trials that supported the approval, said in a press release. “XELJANZ provides people living with ulcerative colitis and their prescribing physicians with a new oral treatment option.” The approval follows a recent recommendation from FDA’s advisory panel – the Gastrointestinal Drugs Advisory Committee (GIDAC) – whose members voted unanimously (15–0) to extend the induction dosage period of Xe
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