#United States #AbbVie #North Chicago #Pediatrics #Resankizumab

Resankizumab’s FDA Approval: A New Era for Pediatric Psoriasis Treatment

In a groundbreaking announcement on June 26, 2026, AbbVie (NYSE: ABBV) revealed that the U.S. Food and Drug Administration (FDA) has approved Resankizumab for treating pediatric patients aged six years and older suffering from moderate to severe plaque psoriasis and active psoriatic arthritis. This marks a significant milestone, as Resankizumab becomes the first and only IL-23 inhibitor approved in the United States specifically for children under 40 kg.

The FDA’s approval includes a new 55 mg prefilled syringe designed for weight-based dosing, allowing for tailored treatment for pediatric patients weighing less than 40 kg. Prior to this, only the 150 mg prefilled syringe and pen formulation were approved for patients over that weight, highlighting the need for effective treatment options for younger and smaller patients.

Dr. Roopal Thakkar, the executive vice president of research & development and chief scientific officer at AbbVie, stated, “The impact of psoriasis and psoriatic arthritis extends beyond skin and joints. These conditions can become central in daily life, disrupting crucial childhood experiences. We are proud that Resankizumab has been approved in the U.S. as the first and only IL-23 inhibitor for children over six with a body weight of 40 kg or less. Expanding access to proven therapies can greatly support better disease management for families facing these chronic conditions.”

Approximately 30% of psoriasis patients show symptoms by the age of 18, with around 20,000 children under the age of ten diagnosed with psoriasis each year in the U.S. It is estimated that 14,000 of these children also have psoriatic arthritis, which can significantly impact their physical functionality, daily activities, and place added stress on caregivers.

Leah M. Howard, J.D., the president and CEO of the National Psoriasis Foundation, commented, “For children suffering from immune-mediated conditions, the focus of their childhood often revolves around medical appointments, uncertainties about the future, and the psychological burdens of living with a chronic disease. Providing an approved treatment option for both skin and joint conditions is a long-awaited new alternative for families, offering hope as they navigate the complexities of these diseases.”

Supporting Data for Pediatric Approval

The pediatric indication for Resankizumab was supported by data from the Phase 3 OptIMMize clinical trial program (NCT04435600, NCT04862286). This included results from two previous pharmacokinetic cohorts, a randomized, evaluator-blinded, active-controlled cohort (ages 12-18), and an open-label cohort (ages 6-12). The approval of psoriatic arthritis indications in children was supported not only by the OptIMMize Pediatric Psoriatic Arthritis clinical trial program but also by appropriate pharmacokinetic modeling and simulation analyses based on clinical trials for adult psoriatic arthritis.

The safety profile observed in pediatric patients receiving Resankizumab for psoriasis aligns with the established safety profile in adult patients.

Dr. Amy S. Paller, M.D., chair of dermatology and professor of pediatrics at Northwestern University Feinberg School of Medicine, and principal investigator of the OptIMMize program, noted, “In part two of the OptIMMize clinical trial program, Resankizumab showed clinically meaningful improvements based on sPGA and PASI metrics at 16 weeks, with responses maintained over time. Such clinical efficacy, combined with weight-based dosing for younger patients, may assist physicians in better supporting a broad range of children suffering from plaque psoriasis or psoriatic arthritis.”

About Resankizumab

Resankizumab is an IL-23 inhibitor that selectively binds to the p19 subunit of IL-23, blocking its action. IL-23 is a cytokine involved in the inflammatory process, and is believed to play a role in several chronic immune-mediated diseases. Resankizumab is also approved in the U.S. and by the European Medicines Agency for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis in adults.

About AbbVie

AbbVie is committed to developing innovative and effective medicines to address serious global health challenges. The company focuses on delivering solutions for complex medical issues, improving the lives of individuals through its work in immunology, neuroscience, oncology, and aesthetics. For more information about AbbVie, visit www.abbvie.com. The company also shares updates on LinkedIn, Facebook, Instagram, X, and YouTube.