FDA Approves Stelara for Adults with Moderate-to-Severe Active Crohn’s Disease

FDA Approves Stelara for Adults with Moderate-to-Severe Active Crohn’s Disease
Janssen Biotech recently announced that the company's Stelara (ustekinumab) for the treatment of moderate-to-severe active Crohn’s disease in adults, has been approved by the U.S. Food and Drug Administration (FDA). Stelara is the first approved biologic treatment for Crohn’s that targets interleukin (IL)-12 and IL-23 cytokines — which are known to play a critical role in immune and inflammatory responses. Use is restricted to patients who either failed completion or were intolerant to treatment with immunomodulators or corticosteroids – but who never failed treatment with tumor necrosis factor (TNF) blockers or, who failed completion or were intolerant to treatment with one or more TNF blockers. The approval was based on results from a clinical trial program that included three pivotal clinical studies in 1,300 patients: The UNITI-1 induction study (NCT01369329) found that Stelara was capable of inducing clinical response and remission in patients who had previously failed or were intolerant to treatment with one or more TNF blockers. Study results showed that 34% of patients reported relief from Crohn’s disease symptoms six weeks after receiving a one-time intravenous (IV) infusion of Stelara. The UNITI-2 induction study (NCT01369342) showed that Stelara induced remission in patients who had previously failed or were intolerant to conventional therapy with immunomodulators or corticosteroids, the majority of whom had never received treatment with TNF blockers. Relief from Crohn’s symptoms was reported in 56 percent of patients six weeks after the IV infusion. The IM-UNITI maintenance study (NCT01369355) evaluated patients who achieved clinical response eight weeks after a single IV infusion of Stelara in the two UNITI-1 and UNIT
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