Janssen files at FDA and EMA seeking approval for Stelara (ustekinumab) to treat moderately to severely active Crohn's disease.

Janssen Biotech, Inc. and Janssen-Cilag International NV (Janssen) announced the submission of a Biologics License Application (BLA) to the 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.

Data from the Phase III UNITI clinical development program, 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.

Comment: 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.