Stelara Approved in US to Treat Moderate-to-Severe Ulcerative Colitis

Stelara Approved in US to Treat Moderate-to-Severe Ulcerative Colitis
The U.S. Food and Drug Administration (FDA) has approved Stelara (ustekinumab) for the treatment of adults with ulcerative colitis (UC) that is moderately to severely active, Janssen Pharmaceuticals, Stelara’s developer and part of Johnson & Johnson, announced. The FDA’s decision follows the approval by the European Commission in September for the same condition. "Because of the individual nature of ulcerative colitis, what works for one patient may not work for another. That is why it is so critical that our ulcerative colitis patients have many different treatment options available to them," Caren Heller, MD, MBA, chief scientific officer at the Crohn's & Colitis Foundation, said in a press release. "The approval of STELARA is extremely important for patients living with moderate to severe ulcerative colitis. STELARA gives patients another option to, hopefully, induce remission and help manage their disease," Heller added. Stelara is a biologic agent that works by inhibiting the activity of two pro-inflammatory proteins, interleukin (IL)-12 and IL-23. The levels of these proteins are abnormally high in patients with inflammatory bowel disease (IBD). The FDA’s decision was based on the results from the multicenter, randomized, double-blind and placebo-controlled Phase 3 UNIFI trial (NCT02407236). These results were published in the New England Journal of Medicine, in a study titled “Ustekinumab as Induction and Maintenance Therapy for Ulcerative Colitis.” The study, which enrolled a total of 961 patients, was divided into two phases — an induction part followed by a maintenance phase. In the induction phase, participants were given a single dose of Stelara — delivered as an intravenous or into the vein (IV) infusion at a do
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