Janssen Submits Crohn’s Disease Drug STELARA for Approval in the United States and European Union

Janssen Submits Crohn’s Disease Drug STELARA for Approval in the United States and European Union

Janssen Biotech, Inc. and Janssen-Cilag International NV, both part of the Janssen Pharmaceutical Companies of Johnson & Johnson, recently announced the submission of the company’s product STELARA® (ustekinumab), developed as a potential treatment for moderate to severe Crohn’s disease in adult patients, to the U.S. Food and Drug Administration (FDA)’s Biologics License Application (BLA) and to a Grouped Type II Variation/Extension Application from the European Medicines Agency (EMA).

STELARA is a human monoclonal antibody able to target two specific molecules, interleukin (IL)-12 and IL-23 cytokines, which are thought to be involved in immune-mediated diseases such as Crohn’s disease. STELARA has been so far approved as a treatment option for active psoriatic arthritis and moderate to severe plaque psoriasis, both autoimmune diseases, in several countries.

The submission of STELARA to the FDA and EMA was based on the positive results from the Phase 3 UNITI clinical development program assessing the safety and efficacy of the drug in patients with moderate to severe active Crohn’s disease. The program included three different clinical trial studies – UNITI-1, UNITI-2 and IM-UNITI, and showed that STELARA could induce a positive clinical response with improvement in disease symptoms, quality of life, and a significant reduction in inflammation, and most importantly, induce disease remission in this patient population. Janssen plans to present part of the data of the UNITI studies in future medical congresses.

“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 Dr. Newman Yeilding, Head of Immunology Development, Janssen Research & Development, LLC in a press release. “We are pleased to submit applications seeking approval of STELARA® for the treatment of moderately to severely active Crohn’s disease in the U.S. and in Europe, and we look forward to collaborating with health authorities throughout the review process.”

Crohn’s disease is a condition characterized by the chronic inflammation of the gastrointestinal tract, causing abdominal pain and tenderness, rectal bleeding, frequent diarrhea, weight loss and fever. The disease is estimated to affect more than 5 million individuals worldwide, including around 700,000 Americans and almost 250,000 Europeans. There is currently no cure for Crohn’s disease, though potential approvals such as this one for STELARA aim to help improve patient outcomes for those with the disease.

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