Janssen seeks approval of Stelara for Crohn's disease
US firm Janssen Biotech and Belgian-based Janssen-Cilag International, both subsidiaries of US health care giant Johnson & Johnson (NYSE: JNJ), have submitted applications to the US Food and Drug Administration and the European Medicines Agency seeking approval of Stelara (ustekinumab) to treat adult patients with moderately to severely active Crohn’s disease.
Stelara is a human monoclonal antibody which 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.
The drug has previously received approval for the treatment of moderate to severe plaque psoriasis and active psoriasis arthritis.
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