SKYRIZI® (risankizumab-rzaa) Now FDA Approved for Pediatric Use in Psoriatic Disease
The approval adds a 55 mg syringe for weight-based dosing and is backed by Phase 3 pediatric trial data, AbbVie said.
- On Friday, June 26, 2026, the U.S. Food and Drug Administration approved Skyrizi for children six years and older with moderate-to-severe plaque psoriasis or active psoriatic arthritis.
- Approximately 30% of people who develop psoriasis experience symptoms before age eighteen; each year, roughly 20,000 children in the U.S. are diagnosed with psoriasis and an estimated 14,000 are impacted by psoriatic arthritis.
- AbbVie introduced a new 55 mg pre-filled syringe supporting weight-based dosing for patients weighing less than 40 kg, while the currently available 150 mg syringe and pen remain approved for those weighing 40 kg or greater.
- Roopal Thakkar, executive vice president of research and development at AbbVie, stated that plaque psoriasis "can shape daily life and disrupt important childhood experiences," underscoring the clinical need for pediatric treatment options.
- AbbVie offers a co-pay card reducing out-of-pocket costs to $0 per month for eligible, commercially insured patients; healthcare providers must monitor for infections and tuberculosis during and after Skyrizi treatment.
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SKYRIZI® (risankizumab-rzaa) Now FDA Approved for Pediatric Use in Psoriatic Disease
SKYRIZI (risankizumab-rzaa) is now approved for patients six years of age and older with moderate-to-severe plaque psoriasis or active psoriatic arthritisApproval includes a new 55 mg pre-filled syringe to support weight-based dosing for those patients weighing less than 40 kgSKYRIZI…
FDA approves Skyrizi for pediatric use in psoriatic disease
The FDA approved risankizumab-rzaa for children aged at least 6 years with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy or active psoriatic arthritis, AbbVie announced in a press release. In addition, the FDA approved a new 55 mg prefilled syringe to support weight-based dosing for patients who weigh less than 40 kg. A 150 mg prefilled syringe and
AbbVie (NYSE:ABBV) jumps $18 billion Friday, beats Apogee as Skyrizi FDA decision comes Monday
AbbVie soared 4.2% to a 52-week high Friday, adding $18 billion in equity value—surpassing the $10.9 billion cash price for its Apogee buyout—even though the deal won’t boost adjusted EPS until 2032; FDA approval for expanded pediatric Skyrizi use came after the close, setting up Monday’s trading for a fresh catalyst.
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