FDA Approves Janssen Biotech’s Drug for Crohn’s Disease
The Food and Drug Administration approved expanding the label for Horsham-based Janssen Biotech’s Stelara product to include its use for the treating Crohn’s disease.
Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract that affects about 700,000 Americans.
The FDA approval of Stelara specified its use in adults 18 or older with moderately to severely active Crohn’s disease who have failed, or were intolerant to, treatment with immunomodulators or corticosteroids but who never failed treatment with a tumor necrosis factor blocker, or who failed or were intolerant to treatment with one or more TNF blockers.
Janssen, a subsidiary of Johnson & Johnson, said Stelera is the first biologic therapy for Crohn’s disease targeting two cytokines that play a key role in inflammatory and immune responses.
Stelera was first approved to treat psoriasis in 2009. In 2013, it was approved to treat adult patients with active psoriatic arthritis.
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