SKYRIZI recieves approval for the treatment of adults with moderately to severe active ulcerative colitis

AbbVie recently announced that the European Commission has approved SKYRIZI for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy.

“Ulcerative colitis is a chronic, unpredictable and sometimes debilitating disease, and people living with the condition need sustained symptom relief,” said Edouard Louis, M.D., Ph.D., professor and head of gastroenterology, Liège University Hospital, dean of faculty, Liège University, and INSPIRE trial investigator. “Patients treated with SKYRIZI in the INSPIRE and COMMAND clinical trials experienced significant improvements in clinical remission and mucosal healing. These are important findings as mucosal healing goes beyond symptom management to restoration of the intestinal lining and is associated with improved long-term outcomes. This approval introduces a new treatment option to help patients with UC reach their long-term treatment goals,”

Ulcerative Colitis affects approx. 5 million people around the world, and the incidence is increasing worldwide. The common signs and symptoms of UC include diarrhea, abdominal pain, blood in the stool, urgency to defecate, passing mucus from the rectum and rectal pain and bleeding. Because of the pain and discomfort, patients commonly lack the ability or desire to pursue everyday activities.

“The approval of SKYRIZI for the treatment of UC provides physicians with a new treatment option that is proven to help a wide range of patients with varying degrees of prior therapy use, including conventional or biological therapy. In Phase 3 trials we observed positive results in mucosal healing particularly in patients without previous biologic experience or JAK inhibitor failure,” said Roopal Thakkar, M.D., executive vice president, research & development, and chief scientific officer, AbbVie.

Futhermore, the recommended SKYRIZI induction dose is 1,200 mg administered by intravenous infusion at week 0, week 4 and week 8.

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Related Topics and Keywords

AbbVie, Active Ulcerative Colitis, SKYRIZI® (risankizumab)