The US Food and Drug Administration (FDA) has approved secukinumab (Cosentyx®, Novartis) for the treatment of individuals aged 12 years and older with moderate-to-severe hidradenitis suppurativa (HS). The approval makes secukinumab the first interleukin-17A (IL-17A) inhibitor available for this patient population and introduces a weight-based biologic treatment option for adolescents.1
HS is a chronic inflammatory skin disease characterised by recurrent, painful nodules and abscesses that can rupture and lead to scarring. The condition frequently begins around puberty, with more than half of patients developing symptoms during adolescence.
“HS often begins in adolescence and can cause irreversible scarring and disabilities,” said Dr Alexa B. Kimball, MD, MPH, Professor of Dermatology at Harvard Medical School and lead investigator of the SUNSHINE (NCT03713619) and SUNRISE (NCT03713632) clinical trials in adult HS. “The approval of Cosentyx represents an important advancement for younger HS patients who have had limited treatment options.”
Targeting IL-17A–driven inflammation
Secukinumab is a fully human monoclonal antibody that selectively inhibits IL-17A, a cytokine involved in inflammatory pathways underlying psoriatic disease and other immune-mediated inflammatory conditions.
The approval applies to adolescents aged 12 years and older weighing at least 30 kg. Weight-based dosing is recommended for this population, with pharmacokinetic modelling suggesting that the dosing approach provides drug exposure comparable to that observed in adults with HS clinical trials.
According to the manufacturer, the decision was supported primarily by efficacy data from the phase 3 SUNSHINE and SUNRISE trials, which evaluated secukinumab in adults with moderate-to-severe HS.2 The studies enrolled 676 and 687 patients respectively. In both trials, significantly more patients receiving secukinumab achieved a hidradenitis suppurativa clinical response compared with placebo, with responses maintained through 52 weeks. The safety profile was consistent with previous studies.
Expanding pediatric indications
This decision marks the fourth pediatric indication for secukinumab. In addition to HS, the therapy is approved for pediatric patients with moderate-to-severe plaque psoriasis, enthesitis-related arthritis and juvenile psoriatic arthritis.
Secukinumab is also approved in adults for several immune-mediated inflammatory diseases, including plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis.
References
- Novartis. Novartis Cosentyx® receives FDA approval for pediatric patients aged 12+ with moderate-to-severe hidradenitis suppurativa. Press release. Available at: https://www.novartis.com/us-en/news/media-releases/novartis-cosentyx-receives-fda-approval-pediatric-patients-aged-12-moderate-severe-hidradenitis-suppurativa (accessed 16 March 2026)
- Kimball AB, Jemec GBE, Sayed CJ, et al. Secukinumab in moderate-to-severe hidradenitis suppurativa (SUNSHINE and SUNRISE): week 16 and week 52 results of two identical, multicentre, randomised, placebo-controlled, double-blind phase 3 trials. Lancet. 2023;401:747–761. doi:10.1016/S0140-6736(23)00022-3.
Citation: Secukinumab becomes first IL-17A inhibitor approved for adolescents with hidradenitis suppurativa. TouchDERMATOLOGY. 16 March, 2026
Disclosure: This article was created by the touchDERMATOLOGY team utilizing AI as an editorial tool (ChatGPT [Large language model]. https://chat.openai.com/chat.) The content was developed and edited by human editors. No funding was received in the publication of this article.
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