Novartis wins FDA approval for Cosentyx to treat paediatric HS patients

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Source: Pharmaceutical Technology

Original: https://www.pharmaceutical-technology.com/news/novartis-fda-approval-cosentyx/...

Published: Mon, 16 Mar 2026 09:41:52 +0000

Novartis has received approval from the US FDA for Cosentyx (secukinumab) for the treatment of pediatric patients 12 years of age and older with moderate to severe hidradenitis suppurativa (HS).[1][2] Cosentyx is the only IL-17A inhibitor approved for this group of patients.[1][3] The approval expands biologic treatment options for adolescents with HS, where options have previously been limited.[1][3] HS is a chronic inflammatory skin disease characterized by recurrent boil-like nodules that can rupture into painful sores and lead to irreversible scarring.[3] The disease often begins in puberty, and more than half of patients experience the first symptoms in adolescence.[3] Approval for the pediatric indication is supported by controlled studies in adults with HS, pharmacokinetic modeling from adult HS and psoriasis studies, and data from pediatric clinical trials in other indications.[3] Weight-based dosing for patients weighing at least 30 kg produces drug exposure comparable to adult HS patients.[3]