FDA Approves Secukinumab for Pediatric Patients 12 Years and Older with HS

The US Food and Drug Administration (FDA) has approved secukinumab for the treatment of moderate to severe hidradenitis suppurativa (HS) in pediatric patients aged 12 and older, positioning it as the only interleukin (IL)-17A inhibitor currently indicated for this population.1

The approval adds a differentiated biologic option to an area where treatment choices for younger patients have historically been limited. HS is a chronic, systemic inflammatory condition known to be characterized by recurrent, painful, boil-like nodules, causing significant discomfort among individuals living with the disease.2 The nodules resulting from HS can rupture, cause open wounds, and result in permanent scarring.

“Hidradenitis suppurativa (HS) often begins in adolescence and can cause irreversible scarring and disabilities,” Alexa B. Kimball, MD, MPH, lead investigator of the SUNSHINE and SUNRISE clinical trials in adult HS patients, President and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, said in a statement.1 “The approval of [secukinumab] represents an important advancement for younger HS patients who have had limited treatment options.”

HS impacts approximately 1 in 100 people globally and frequently makes its first appearance around puberty, with more than 50% of those reporting symptom onset reporting the disease at the time of adolescence. Secukinumab is a fully human monoclonal antibody designed to directly targeting interleukin-17A, a key cytokine known to drive the inflammatory pathways implicated in several immune-mediated diseases.

The drug carries adult approvals across a broad range of indications, including HS, ankylosing spondylitis, psoriasis, psoriatic arthritis (PsA), and non-radiographic axial spondyloarthritis. On the pediatric side, it is now approved for HS alongside existing indications in plaque psoriasis, enthesitis-related arthritis, and juvenile PsA.

For clinicians managing adolescent HS patients, the approval introduces weight-based dosing for those at or above 30 kg, a regimen designed to achieve drug exposure comparable to that seen in adult HS trials. The pediatric indication was supported by a combination of data. Such findings included well-controlled adult HS studies, pharmacokinetic modeling extrapolated from adult data on HS and psoriasis, and clinical trial reslts from other approved pediatric indications.

In dosing analyses, results also validated the weight-adjusted approach as a reliable replication of the systemic exposure established in adults.
The distinct mechanism of IL-17A inhibition provides prescribers with a targeted therapeutic agent designed for individualization and based on patient weight.

“Hidradenitis suppurativa (HS) affects far more than skin; it impacts confidence, emotional well-being and relationships during a formative period for many pediatric patients,” Brindley Brooks, founder and CEO of HS Connect, said in a statement.1 “For families watching their children struggle, this FDA approval brings hope for earlier intervention.”

References

1. Novartis Cosentyx® receives FDA approval for pediatric patients aged 12+ with moderate to severe hidradenitis suppurativa. Novartis. March 13, 2026. https://www.novartis.com/us-en/news/media-releases/novartis-cosentyx-receives-fda-approval-pediatric-patients-aged-12-moderate-severe-hidradenitis-suppurativa.

2. Montero-Vilchez T, Diaz-Calvillo P, Molina-Leyva A, et al. The Burden of Hidradenitis Suppurativa Signs and Symptoms in Quality of Life: Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2021 Jun 22;18(13):6709. doi: 10.3390/ijerph18136709. PMID: 34206415; PMCID: PMC8293810.