US FDA Approves Janssen Biologic Stelara for Treatment of Mod-Severe Crohn’s Disease

fdaToday, the United States Food and Drug Administration announced the approval of the Janseen Biotech Inc drug Stelara (ustekinumab) for the treatment of moderate-to-severe [active] Crohn’s disease in adults 18 and older who have failed or have been shown to be intolerant to immunomodulator or corticosteroid treatments but never failed treatment with some kind of tumor necrosis factor blocker; or for those who have failed or shown intolerance to at least one TNF blocker. With that, Stelara is the first biologic therapy for Crohn’s Disease with the specific mechanism of targeting intereleukin (IL)-12 and IL-23 cytokines.

These interleukin cytokines play fundamental roles in both inflammatory and immune responses.

“Crohn’s disease is a complex condition to treat, and not all therapies work for every patient,” explains study investigator William J. Sandborn, MD. UCSD School of Medicine Chief of the Division of Gastroenterology, and Professor of Medicine goes on to say, “The FDA approval of Stelara represents an important advancement in treating patients with Crohn’s disease, as this therapy offers an alternate mechanism of action to induce and maintain clinical remission over time. Based on the results of the clinical development program, Stelara has the potential to benefit many adults living with Crohn’s disease.”

Clinical studies of this biologic could be as much as 56 percent more effective in relieving symptoms of Crohn’s disease in only six weeks after an initial, singular, intravenous infusion of Stelara. In fact, the research shows that, for some patients, improvements could be noticed as early as three weeks. In addition to those who responded positively to induction dosing, a majority of those who continued treatment (maintenance doses every 8 weeks) were found to be in remission within 44 weeks.

With that in mind, Janssen Biotech Inc vice president of medical affairs, Andrew Greenspan, MD, comments, “The approval of Stelara for Crohn’s disease underscores our commitment to provide innovative treatment options for people living with chronic inflammatory and immune-mediated diseases.” He goes on to say, “We are confident Stelara will improve the lives of many people living with Crohn’s disease and are committed to ensuring that it is accessible to patients who qualify for this new therapeutic option.”