JNJ Stelara FDA Approval: Pediatric Ulcerative Colitis

Johnson & Johnson’s Stelara (ustekinumab) won FDA approval on Friday for moderately to severely active ulcerative colitis in children ages 2 and older. The decision completes a pediatric sweep: Stelara is now the first monoclonal antibody that does not target TNFα approved for both main forms of pediatric IBD, following its April 15 approval for pediatric Crohn’s disease.

J&J shares closed at $268.04 on the news. Stelara, an IL-12/23 inhibitor first approved for plaque psoriasis in 2009, grew into one of the company’s biggest drugs and later expanded to psoriatic arthritis, adult Crohn’s disease, and adult ulcerative colitis. The new pediatric label adds a niche patient population, not a growth engine.

The mechanism is the point. TNF inhibitors such as infliximab and adalimumab were previously the only biologic options for pediatric ulcerative colitis. Stelara works differently, blocking IL-12 and IL-23, two cytokines that drive separate inflammation pathways. For the roughly 25% to 40% of patients who do not respond to or lose response to anti-TNF therapy, that is a genuinely new option. Newer oral and biologic agents approved for adults have generally lagged behind in pediatric labels, so a second pediatric mechanism matters.

The approval leaned on efficacy data from adult ulcerative colitis studies, plus the 52-week UNIFI-Jr study in 112 pediatric UC patients ages 3 to 17 and pharmacokinetic and safety data from pediatric Crohn’s subjects. The most common side effects were nasopharyngitis, headache, and abdominal pain. Stelara is given as an intravenous induction dose followed by subcutaneous maintenance injections, a regimen pediatric Crohn’s patients already know.

About 100,000 American children and adolescents under 20 live with inflammatory bowel disease, and roughly a quarter of all IBD cases first appear before age 20, so pediatric labels carry real clinical weight. For investors, though, the commercial impact is modest. Pediatric ulcerative colitis is a small population, which is why the FDA granted Orphan Drug Designation. That designation carries seven years of US market exclusivity for the pediatric indication, which could shield this niche from biosimilars even as the adult label loses protection. Stelara’s broader franchise is already shrinking: global sales fell 43% year over year to $1.65 billion in the second quarter as biosimilars launched in early 2025 eroded the adult market. The wider IBD field is crowded with TL1A antibodies and oral IL-23 pills in late-stage trials, but pediatric labels for those agents remain years away, so Stelara has a clear run in children for now.

What to watch next: whether J&J’s next-generation IL-23 drug Tremfya (guselkumab) can absorb Stelara’s decline fast enough, and whether Stelara holds its pediatric IBD position in the meantime.