Stelara Approved to Treat Moderate to Severe Ulcerative Colitis in Europe

Stelara Approved to Treat Moderate to Severe Ulcerative Colitis in Europe
The European Commission (EC) has approved Stelara (ustekinumab) to treat moderately to severely active ulcerative colitis (UC) in adults who are either not responding to, or are intolerant of,  standard therapies or other biologic agents. The decision was announced by Janssen Pharmaceuticals, Stelara’s developer and part of Johnson & Johnson. "Today marks a significant milestone in the treatment of ulcerative colitis," Jan Wehkamp, MD, vice president and Gastroenterology Disease Area leader at Janssen Research & Development, said in a press release. "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." A branch of the the European Medicines Agency (EMA), the Committee for Medicinal Products for Human Use (CHMP), had recommended Stelara's approval for this patient group in late July. Stelara is a biologic agent that works by inhibiting the activity of two proteins, interleukin (IL)-12 and IL-23, which are inflammatory cytokines (molecules that mediate and regulate immune and inflammatory responses) whose levels are abnormally high in patients with inflammatory bowel disease (IBD). The medication is also approved to treat moderate to severe Crohn’s disease, as well as psoriasis and psoriatic arthritis, in both Europe and the U.S. EC approval was based on findings from the multicenter, randomized, double-blind and placebo-controlled Phase 3 UNIFI trial (NCT02407236). This study's main goal was to evaluate the safety and efficacy of Stelara, compared to a placebo, in people with moderate to severe UC. The treatment was given as an intravenous (IV) infusion. The trial was divide
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