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The FDA approval extends Cosentyx into pediatric hidradenitis suppurativa, with use supported by adult studies, pharmacokinetic modeling, and pediatric data from other approved indications.
On March 13, 2026, the US Food and Drug Administration approved Cosentyx, secukinumab, for pediatric patients aged 12 years and older with moderate to severe hidradenitis suppurativa, or HS. The decision makes Cosentyx the only IL-17A inhibitor approved for this population.
The label expansion extends Cosentyx into an adolescent HS population where disease burden can begin early. HS often emerges around puberty, with more than half of patients developing symptoms during adolescence, and the disease can lead to irreversible scarring. The condition is chronic, progressive, and often painful, with diagnosis taking up to 10 years on average. Use in patients aged 12 years and older weighing 30 kilograms or more is supported by well-controlled adult studies, pharmacokinetic modeling extrapolated from adult HS and psoriasis trials, and pediatric clinical trial data from other approved indications.
The approval marks the fourth pediatric indication for Cosentyx and broadens an established immunology franchise. Since its 2015 launch, Novartis said the product has been used by more than 1.8 million patients worldwide and is approved in more than 100 countries.
Source: Novartis
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