Janssen Biotech, Inc. and Janssen-Cilag International NV (Janssen) announced the submission of a Biologics License Application (BLA) to the United States (US) Food and Drug Administration (FDA) and a Grouped Type II Variation/Extension Application to the European Medicines Agency (EMA) seeking approval of Stelara (ustekinumab) for the treatment of adult patients with moderately to severely active Crohn’s disease.  Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract that affects approximately 700,000 Americans and nearly 250,000 Europeans.

“At Janssen, we are committed to addressing the unmet medical needs of patients living with Crohn’s disease through the discovery and development of innovative therapeutics,” said Newman Yeilding, M.D., head of immunology development, Janssen Research & Development, LLC.  “We are pleased to submit applications seeking approval of Stelara for the treatment of moderately to severely active Crohn’s disease in the US and in Europe, and we look forward to collaborating with health authorities throughout the review process.”

Data from the phase 3 UNITI clinical development programme, which includes three studies (UNITI-1, UNITI-2 and IM-UNITI) evaluating the efficacy and safety of Stelara induction and maintenance treatment in patients with moderately to severely active Crohn's disease, served as the basis for the submissions.  Data from the UNITI-2 study were recently presented at the American College of Gastroenterology and United European Gastroenterology Week annual meetings, and results from the UNITI-1 and IM-UNITI studies will be presented at future medical congresses.   

Stelara, approved for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in many countries, is a human monoclonal antibody that targets interleukin (IL)-12 and IL-23 cytokines.  These cytokines are believed to play an important role in immune-mediated diseases, including Crohn’s disease.   

More than five million people worldwide are living with Crohn’s disease and ulcerative colitis—collectively known as inflammatory bowel disease (IBD).3  Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract that affects approximately 700,000 Americans and nearly 250,000 Europeans.  The cause of Crohn’s disease is not known, but the disease is associated with abnormalities of the immune system that could be triggered by a genetic predisposition or diet and other environmental factors.  Symptoms of Crohn’s disease can vary but often include abdominal pain and tenderness, frequent diarrhea, rectal bleeding, weight loss and fever.  There is currently no cure for Crohn’s disease.

Stelara, a human IL-12 and IL-23 antagonist, is approved in the United States for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.  Stelara is also approved for the treatment of adult patients (18 years or older) with active psoriatic arthritis and can be used alone or in combination with methotrexate (MTX).

In the European Union, Stelara is approved for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, MTX or psoralen plus ultraviolet A (PUVA).  Stelara is also indicated for the treatment of moderate to severe plaque psoriasis in adolescent patients from the age of 12 years and older who are inadequately controlled by or are intolerant to other systemic therapies or phototherapies.  In addition, Stelara is approved alone or in combination with MTX for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying antirheumatic drug (DMARD) therapy has been inadequate.

The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to Stelara, which is currently approved for the treatment of moderate to severe plaque psoriasis in 86 countries and psoriatic arthritis in 58 countries.