Janssen submit EMA application for Stelara ® in ulcerative colitis

Janssen's Stelara® approved for expanded use by European Commission

Janssen have completed an EMA application for Stelara ® for a form of inflammatory bowel disease (IBD) – ulcerative colitis 

The Janssen Pharmaceutical Companies of Johnson & Johnson have announced the submission of a Group Type II Variation Application to the European Medicines Agency (EMA) seeking approval of STELARA® (ustekinumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC).

Ustekinumab is a human monoclonal antibody that targets the interleukin (IL)-12 and IL-23 cytokines, which are believed to play an important role in the immune and inflammatory responses seen in immune-mediated diseases, such as UC and Crohn’s disease.

Crohn’s disease and ulcerative colitis (UC), collectively known as inflammatory bowel disease (IBD), affect approximately three million people in Europe; of these, one million are living with UC. 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 mucus. It is the result of an abnormal response by the body’s immune system. Symptoms vary, but may include loose and more urgent bowel movements, persistent diarrhoea, abdominal pain, bloody stools, loss of appetite, weight loss and fatigue.

The EMA application for Stelara follows a supplemental Biologics License Application (sBLA) made to the United States’ Food and Drug Administration (FDA) on December 20, 2018, which also seeks approval of ustekinumab for the treatment of adults with moderately to severely active UC.

“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”

The EMA application for Stelara submission is based on data from the Phase 3 UNIFI global clinical development programme. Janssen shared the new data on STELARA ® for ulcerative colitis in October 2018. The programme includes two studies (one induction and one maintenance study) evaluating the efficacy and safety of ustekinumab for the treatment of moderately to severely active UC in adults.

The common (in ≥1% of patients) adverse reactions reported in controlled periods of the adult psoriasis, psoriatic arthritis and Crohn’s disease clinical studies with ustekinumab as well as in the post-marketing experience are: arthralgia, back pain, diarrhoea, dizziness, fatigue, headache, injection site erythema, infection site pain, myalgia, nasopharyngitis, nausea, oropharyngeal pain, pruritus, upper respiratory tract infection and vomiting.

In 2018 Janssen showed that Ustekinumab reduced rates of hospitalisation for Crohn’s.

Jaime Oliver, MD, Janssen Therapeutic Area Lead, Immunology, Europe, Middle East & Africa, Cilag GmbH International said, “Ulcerative colitis (UC) is a chronic, painful and debilitating condition that has a significant impact on quality of life. UC affects up to one million people across Europe, and some of these patients struggle to achieve and maintain high levels of clinical response with currently available therapies. This submission for ustekinumab in UC brings us one step closer to providing a new treatment option to help address this important unmet need.”

Scott E. Plevy, MD, Gastroenterology Disease Area and IL-23 Pathway Leader, Janssen Research & Development, LLC said, “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. This submission builds upon our 20-year legacy of research and development to address unmet needs of people living with inflammatory bowel diseases.”