HORSHAM, PA, USA I December 20, 2018 I The Janssen Pharmaceutical Companies of Johnson & Johnson announced today 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. Data from the Phase 3 induction study were recently presented at the 2018 American College of Gastroenterology and United European Gastroenterology Week annual meetings, and results from the Phase 3 maintenance study will be presented at future scientific meetings next year. 

“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, LLC.

About Ulcerative Colitis

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.1 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.2

About STELARA® (ustekinumab)

STELARA® (ustekinumab), a human IL-12 and IL-23 antagonist, is approved in the United States for the treatment of: 1) adults and children 12 years and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; 2) adult patients (18 years or older) with active psoriatic arthritis, used alone or in combination with methotrexate (MTX); 3) adult patients (18 years and older) with moderately to severely active Crohn’s disease who have failed or were intolerant to immunomodulators or corticosteroids; or failed or were intolerant to anti-TNF therapies.

The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to STELARA®.

About the Janssen Pharmaceutical Companies of Johnson & Johnson

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at http://www.janssen.com/. Follow us at http://www.twitter.com/JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

  1. World IBD Day. Home. Available at http://www.worldibdday.org/index.html. Accessed September 11, 2018.
  2. Crohn’s & Colitis Foundation of America. What is Ulcerative Colitis? Available at http://www.crohnscolitisfoundation.org/what-are-crohns-and-colitis/what-is-ulcerative-colitis/. Accessed September 11, 2018.

SOURCE: Janssen