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News - AbbVie Expands SKYRIZI Access to Pediatric Patients with New FDA Approval and Prefilled Syringe Option

July 2026 | Jack Overell – Head of Production, SAE Media Group

AbbVie has announced that the U.S. Food and Drug Administration (FDA) has approved SKYRIZI (risankizumab-rzaa) for the treatment of children aged six years and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, as well as children with active psoriatic arthritis.

The approval is accompanied by the launch of a new 55 mg prefilled syringe (PFS) designed to support weight-based dosing for pediatric patients weighing less than 40 kg. Patients weighing 40 kg or more will continue to receive treatment through the existing 150 mg prefilled syringe and autoinjector pen presentations.

With this regulatory milestone, SKYRIZI becomes the first and only IL-23 inhibitor approved in the United States for pediatric patients aged six years and older weighing less than 40 kg with either plaque psoriasis or psoriatic arthritis.

According to AbbVie, the expanded indication addresses a significant unmet need among younger patients affected by chronic inflammatory diseases. Approximately 30% of individuals who develop psoriasis experience symptoms before the age of 18, while thousands of children in the United States are diagnosed each year with psoriasis or psoriatic arthritis. These conditions can affect mobility, participation in daily activities, and overall quality of life, while also creating additional challenges for caregivers.

“Plaque psoriasis and psoriatic arthritis can affect much more than skin and joints – these conditions can shape daily life and disrupt important childhood experiences,” said Roopal Thakkar, M.D., Executive Vice President, Research and Development and Chief Scientific Officer at AbbVie. “Expanding access to treatments with proven efficacy supports improved disease management and extends established standards of care to younger patients.”

The FDA approval is supported by data from AbbVie’s Phase 3 OptIMMize clinical trial program, which evaluated SKYRIZI in pediatric patients with plaque psoriasis. The development program included pharmacokinetic studies, randomized controlled cohorts, and open-label evaluations in children ranging from six to under 18 years of age. Approval for pediatric psoriatic arthritis was supported by results from the psoriasis program alongside pharmacokinetic modelling based on established adult psoriatic arthritis studies.

Clinical findings demonstrated meaningful improvements in disease activity, with responses maintained through continued treatment. Importantly, the safety profile observed in pediatric patients was consistent with the established safety profile seen in adults treated with SKYRIZI.

Amy S. Paller, M.D., Chair of Dermatology and Professor of Pediatrics at Northwestern University Feinberg School of Medicine and an investigator in the OptIMMize program, highlighted the potential benefits of the new dosing options.

“At Week 16 in part two of the OptIMMize psoriasis clinical trial program, risankizumab demonstrated clinically meaningful improvements in response measures, with responses maintained long-term with continued treatment,” Paller said. “These clinical responses, combined with weight-based dosing for younger patients, may help physicians better support a broad range of children living with plaque psoriasis or psoriatic arthritis.”

From a drug delivery perspective, the approval of the new 55 mg prefilled syringe represents an important development within the pediatric biologics landscape. Weight-based dosing often presents challenges in pediatric populations, and tailored presentation formats can help optimize administration while supporting dosing accuracy and ease of use for healthcare providers.

The approval also reflects a broader industry trend toward expanding biologic therapies into pediatric indications while introducing delivery systems that better accommodate the specific needs of younger patients.

AbbVie noted that eligible commercially insured patients may be able to access SKYRIZI through support programs designed to reduce out-of-pocket costs, while additional assistance is available for qualifying patients with limited or no insurance coverage.

SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively targets the p19 subunit of the cytokine IL-23, which plays a key role in inflammatory pathways associated with immune-mediated diseases. In addition to psoriasis and psoriatic arthritis, the therapy is approved for Crohn’s disease and ulcerative colitis in adult patients.

For the prefilled syringe sector, the introduction of a pediatric-specific presentation highlights the growing focus on patient-centered drug delivery design, where dosing flexibility, usability, and treatment accessibility are becoming increasingly important components of biologic therapy development.

Editor’s Corner



WHAT IS CPD?

CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

CPD AND PROFESSIONAL INSTITUTES

There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

GLOBAL CPD

Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

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