FDA approves AbbVie's Skyrizi for children with psoriatic disease

The U.S. Food and Drug Administration has approved AbbVie's (NYSE: ABBV) Skyrizi (risankizumab-rzaa) for the treatment of children six years of age and older with moderate-to-severe plaque psoriasis or active psoriatic arthritis, according to a company statement.

The approval includes a new 55 mg pre-filled syringe designed to support weight-based dosing for patients weighing less than 40 kg. The existing 150 mg pre-filled syringe and pen remain approved for patients weighing 40 kg or more.

AbbVie claims Skyrizi is the first IL-23 inhibitor approved in the U.S. for pediatric patients six years of age and older weighing less than 40 kg with plaque psoriasis or psoriatic arthritis.

The pediatric psoriasis approval is supported by data from the Phase 3 OptIMMize clinical trial program, which included pharmacokinetic cohorts, a randomized efficacy assessor-blinded active controlled cohort for patients ages 12 to under 18, and a single-arm open-label cohort for patients ages 6 to under 12. The pediatric psoriatic arthritis approval relied on data from the same trial program along with population pharmacokinetic modeling based on adult psoriatic arthritis studies.

The safety profile observed in pediatric plaque psoriasis patients was consistent with the established adult safety profile, according to AbbVie. Common side effects in patients treated for plaque psoriasis and psoriatic arthritis include upper respiratory infections, headache, fatigue, injection site reactions, and fungal skin infections.

According to published data cited by AbbVie, approximately 30% of people who develop psoriasis experience symptoms before age 18, with roughly 20,000 children under ten diagnosed with psoriasis annually in the U.S. An estimated 14,000 children are affected by psoriatic arthritis.

Skyrizi is also approved by the FDA for plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis in adults.

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