The US FDA has approved Cosentyx (secukinumab) for the treatment of pediatric patients aged 12 years and older with moderate to severe hidradenitis suppurativa, Novartis announced on 13 March 2026. The decision makes Cosentyx the only IL-17A inhibitor approved for this population and marks the fourth pediatric indication for the drug. Prior to this, adalimumab and its biosimilars were the only biologics available for HS, all operating through TNF-α inhibition. Cosentyx thus introduces a differentiated mechanism of action to pediatric HS care for the first time.
The approval covers patients aged 12 and older weighing 30 kg or more, with dosing tailored by body weight. Novartis did not conduct a standalone pivotal trial in adolescents with HS. Instead, the US FDA based its decision on pharmacokinetic modeling extrapolated from the adult HS program and from pediatric clinical trial data generated in other Cosentyx indications, including plaque psoriasis, enthesitis-related arthritis, and juvenile psoriatic arthritis. Dosing analysis predicted that weight-based administration in pediatric patients would achieve drug exposures comparable to those observed in adults with HS, the company said.
The adult efficacy and safety data underpinning the approval came from the Phase III SUNSHINE and SUNRISE trials. Both studies met their primary endpoint, demonstrating statistically significant superiority over placebo on the Hidradenitis Suppurativa Clinical Response (HiSCR) measure at Week 16. In SUNSHINE, HiSCR rates were 45% and 42% for the every-two-weeks and every-four-weeks dosing regimens, respectively, compared with 34% for placebo. SUNRISE produced similar results: 42% and 46% versus 31%. Response rates continued to increase through Week 52 in patients maintained on secukinumab. Safety findings were consistent with the established profile of the drug across its other indications, with candida infections and potential inflammatory bowel disease risk noted as class-related considerations.
Hidradenitis suppurativa affects approximately 1 in 100 people globally, and more than half of patients develop symptoms during adolescence. The disease causes recurring abscesses that can rupture into draining wounds, frequently leading to scarring, chronic pain, and functional disability. Diagnostic delays averaging up to 10 years are common. For adolescents, the condition carries additional psychosocial consequences during a formative period of development. Until now, treatment options for this age group were largely limited to off-label use of antibiotics, immunosuppressants, and adalimumab, none of which offered an alternative biologic pathway when TNF-α inhibition proved insufficient. The Cosentyx approval joins a competitive landscape that includes adalimumab and its biosimilars as well as bimekizumab (Bimzelx, UCB), a dual IL-17A/F inhibitor approved for adult HS in 2024, though no other IL-17-targeting agent currently holds a pediatric HS indication. Several additional molecules are in late-stage development, including sonelokimab (MoonLake Immunotherapeutics), an IL-17A/F nanobody in Phase III trials, and povorcitinib (Incyte), an oral JAK1 inhibitor that could become the first oral targeted therapy for HS. These programs reflect sustained industry interest in a disease that, until recently, had only one approved biologic mechanism for over eight years.
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