Janssen Submits Application to FDA for Stelara as Ulcerative Colitis Treatment

Janssen Pharmaceutical announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of Stelara (ustekinumab) for the treatment of adults with moderately to severely active ulcerative colitis. Stelara is the first and only biologic targeting interleukin (IL)-12 and IL-23 cytokines, which evidence suggests play an important role in inflammation associated with auto-immune conditions, such as ulcerative colitis. Stelara is approved in many countries, including the U.S., for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis and moderate to severe Crohn's disease.

"We're excited to bring this innovative therapy, with a proven track record in Crohn's and other immune diseases, one step closer to being available for people living with ulcerative colitis," said Scott E. Plevy, M.D., Gastroenterology Disease Area and IL-23 Pathway Leader, Janssen Research & Development, LLC. "This submission builds upon our 20-year legacy of research and development to address unmet needs of people living with inflammatory bowel diseases."

The submission is based on data from the Phase 3 UNIFI global clinical development program, which included two studies (one induction and one maintenance study) evaluating the efficacy and safety of STELARA for the treatment of moderately to severely active ulcerative colitis in adults.

"We hear from so many people with ulcerative colitis that there is a significant need for additional therapeutic options. Stelara will offer a new mechanism of action that blocks IL-12 and IL-23 proteins and thereby inflammation of the colon," said Andrew Greenspan, M.D., Vice President, Immunology Medical Affairs, Janssen Scientific Affairs.

More than five million people worldwide are living with Crohn's disease and ulcerative colitis—commonly known as IBD. Ulcerative colitis, or UC, affects nearly 907,000 people in the United States, with approximately 38,000 new cases diagnosed each year. UC is a chronic disease of the large intestine, also known as the colon, in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers, that produce pus and mucous. It is the result of an abnormal response by your body's immune system. Symptoms vary but may include loose and more urgent bowel movements, persistent diarrhea, abdominal pain, bloody stool, loss of appetite, weight loss and fatigue.

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