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EC approves expanded use of Stelara for moderately to severely active ulcerative colitis

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The European Commission on Wednesday approved the expanded use of Stelara for adults with moderately to severely active ulcerative colitis, according to a company press release.

The expanded use, according to the release, is for patients who have had an inadequate response with, lost response to, or were intolerant to either conventional or biologic therapies, or have medical contraindications to those therapies.

“The devastating impact of ulcerative colitis on the lives of people with this condition is often underestimated,” Silvio Danese, MD, PhD, head of the Inflammatory Bowel Diseases Centre at Humanitas Research Hospital in Milan, said in the release. “Typically, ulcerative colitis first presents in young adults at a time when they are still in education or starting their careers – often limiting their ability to achieve their personal goals. Whilst there is no cure yet for ulcerative colitis, treatments which can help prevent the flare up of symptoms and allow people to get on with their lives are hugely important. For this reason, the approval of ustekinumab in ulcerative colitis is welcome news and will provide a valuable therapeutic option for both patients and their doctors.”

The approval is based on data from the phase 3 UNIFI trial, which was presented at Congress of the European Crohn’s and Colitis Organisation.

“Many hundreds of thousands of people in Europe struggle with one of the two types of inflammatory bowel disease – Crohn’s disease and ulcerative colitis – and are in urgent need of effective treatment options,” Jan Wehkamp, MD, Gastroenterology Disease Area Leader at Janssen Research & Development LLC, said in the release. “Ustekinumab has been available to people with Crohn’s disease since it was approved in 2016, and thanks to the patients who enrolled in the UNIFI clinical trial program and their willingness to participate, we are delighted it will now be available to people with ulcerative colitis, offering them a chance of durable remission and relief from the often painful and debilitating symptoms.”

Disclosure: Danese reports serving as a consultant for Janssen.