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news.Janssen Biotech and Janssen-Cilag International have submitted applications in the US and Europe seeking approval of Stelara (ustekinumab) to treat adult patients with moderately to severely active Crohn's disease.
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A biologics license application (BLA) was submitted to the US Food and Drug Administration (FDA), while a Grouped Type II variation/extension application was filed with the European Medicines Agency (EMA).
The company submitted the applications based on data from the Phase 3 UNITI clinical development program, which includes three studies evaluating the efficacy and safety of Stelara induction and maintenance treatment in patients with moderately to severely active Crohn’s disease,
Stelara, an interleukin-12 and interleukin-23 antagonist, is currently approved in both areas to treat of moderate-to-severe plaque psoriasis and active psoriatic arthritis.
The Janssen Pharmaceutical Companies of Johnson & Johnson have exclusive global marketing rights to Stelara, which is currently cleared to treat moderate to severe plaque psoriasis in 86 countries and psoriatic arthritis in 58 countries.
Janssen said Stelara may lower the patient’s ability to fight infections and increase risk of infections.
Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract that affects about 700,000 people in the US and around 250,000 Europeans.
The disease is associated with abnormalities of the immune system that may be triggered due to a genetic predisposition or diet and other environmental factors.