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The expansion covers those who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies.
“The devastating impact of ulcerative colitis on the lives of people with this condition is often underestimated. 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,” said Professor Silvio Danese, Head of the Inflammatory Bowel Diseases Centre at Humanitas Research Hospital, Milan, Italy. “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.”
“Today marks a significant milestone in the treatment of ulcerative colitis,” said Jan Wehkamp, MD, Vice President, Gastroenterology Disease Area Leader, Janssen Research & Development, LLC. “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.
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 programme 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.”
The EC approval is based on data from the pivotal Phase III UNIFI trial programme – a programme that was split into an initial Induction study (UNIFI-I) of at least eight weeks, followed by a maintenance study (UNIFI-M) of 44 weeks – both of which demonstrated ustekinumab’s efficacy as a treatment option for patients with moderately to severely active UC who demonstrated an inadequate response to or were unable to tolerate conventional (that is, corticosteroids or immunomodulators) or biologic (that is, one or more tumour necrosis factor-alpha antagonists and/or vedolizumab) therapies.