FDA approves new indication for Janssen’s Stelara

Janssen has received the Food and Drug Administration's green light for Stelara (ustekinumab) for the treatment of adult patients with moderately to severely active ulcerative colitis, or UC.

UC is a serious, chronic and progressive immune-mediated inflammatory disease of the large intestine, affecting approximately 910,000 people in the United States. STELARA is the first and only approved biologic therapy for UC that targets the interleukin (IL)-12 and IL-23 cytokines. The IL-12 and IL-23 cytokines have been shown to play an important role in inflammatory and immune responses.

"At Janssen, we have a longstanding commitment to developing innovative new options that can help address the unmet treatment needs for those living with immune-mediated diseases," said David Lee, therapeutic area head, immunology, Janssen research and development. "With today's milestone, Stelara has received its fifth FDA approval since 2009, a testament to our unwavering focus on delivering treatments for patients who have limited therapeutic options."

Since receiving approval in September 2009 for the treatment of adults living with moderate to severe plaque psoriasis, Stelara has received approval for four additional indications: adolescent patients with moderate to severe plaque psoriasis, adults with active psoriatic arthritis, adults with moderately to severely active Crohn's disease, and now adults with moderately to severely active ulcerative colitis.