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Janssen's Stelara becomes first European-approved biologic IL-12/IL-23 inhibitor for ulcerative colitis

Published on 05/09/19 at 02:39pm

Janssen has announced that its therapy Stelara (ustekinumab) hass secured a label expansion from the European Commission, approving the drug in the treatment of moderately to severely active ulcerative colitis (UC), making it the first biologic therapy available in the region to selectively target the IL-12/IL-23 pathway.

Specifically, the therapy is now indicated in adults 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 decision was based on Phase 3 data illustrating Stelara’s efficacy in this indication, and follows a previous positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) back in July.  

“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,” explained Professor Silvio Danese, Head of the Inflammatory Bowel Diseases Centre at Humanitas Research Hospital in Milan. “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.”

Dr Jan Wehkamp, Vice President, Gastroenterology Disease Area Leader at Janssen, added: “Today marks a significant milestone in the treatment of ulcerative colitis. 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.”

Janssen also submitted the drug to the FDA in this indication in December 2018; the review is currently ongoing.

Matt Fellows

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