U.S. FDA approves AbbVie’s SKYRIZI for ulcerative colitis

The U.S. Food and Drug Administration (FDA) has approved AbbVie’s SKYRIZI (risankizumab-rzaa) for adults with moderately to severely active ulcerative colitis, making it the first IL-23 specific inhibitor approved for both moderate to severe ulcerative colitis and moderate to severe Crohn’s disease. SKYRIZI is now approved for four indications across immune-mediated inflammatory diseases.

“When treating patients with ulcerative colitis, it’s important to prioritize both early and sustained clinical remission as well as endoscopic improvement,” said Edward V. Loftus, Jr., M.D., Maxine and Jack Zarrow Family Professor of Gastroenterology in the division of gastroenterology and hepatology at Mayo Clinic in Rochester, Minnesota. “This approval for SKYRIZI is an important step toward addressing these treatment goals.”

With over 1 million people living with ulcerative colitis, the United States has one of the largest populations affected by this disease and the numbers are continuing to rise. Ulcerative colitis is a form of inflammatory bowel disease (IBD) that causes inflammation in the digestive tract and can result in damage to the colon lining. Patients often experience a range of unpredictable symptoms that impact their daily lives, such as abdominal pain, bloody stool and urgency to use the bathroom. The disease course of ulcerative colitis varies between patients, and in some cases can lead to surgery or complications, including cancer or death.

“Today’s approval of SKYRIZI for ulcerative colitis expands our IBD portfolio and demonstrates our commitment to helping address ongoing needs of patients,” said Roopal Thakkar, M.D., senior vice president, chief medical officer, global therapeutics, AbbVie. “We will continue to invest in transforming the treatment landscape and the lives of people suffering from lBD.”

Dosing of SKYRIZI for this indication includes a 12-week induction period with three 1200 mg doses delivered every four weeks, followed by maintenance therapy of either 180 mg or 360 mg delivered every eight weeks. Following the induction period, SKYRIZI treatment can be maintained at home using an on-body injector (OBI). The OBI is a hands-free device designed with patients in mind that adheres to the body and takes about five minutes to deliver the medication following preparation steps.

Risankizumab (SKYRIZI) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.

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