Cosentyx Becomes First IL-17A Inhibitor Approved for Adolescents in Hidradenitis Suppurativa

Novartis announced that the U.S. Food and Drug Administration has approved Cosentyx (secukinumab) for the treatment of pediatric patients aged 12 years and older with moderate to severe Hidradenitis Suppurativa (HS).

The decision makes Cosentyx the only IL-17A inhibitor currently approved for adolescents with the condition, expanding biologic treatment options for younger patients.

HS is a chronic inflammatory skin disease characterized by recurrent, painful boil-like lesions that can rupture and form open wounds, often leading to permanent scarring. The disease frequently begins around puberty, and more than half of patients develop symptoms during adolescence, highlighting the importance of early and effective treatment.

The pediatric approval is supported by evidence from well-controlled adult clinical studies in HS, along with pharmacokinetic modelling that extrapolated data from adult HS and psoriasis trials. Additional support came from pediatric clinical data generated in other indications for secukinumab. Weight-based dosing analyses showed that pediatric patients weighing at least 30 kg can achieve drug exposure levels comparable to those seen in adults treated for HS.

“Hidradenitis suppurativa often begins in adolescence and can cause irreversible scarring and disabilities,” said Alexa B. Kimball, MD, MPH, lead investigator of the SUNSHINE and SUNRISE clinical trials and President and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center. She noted that the approval represents an important advancement for younger patients who previously had limited treatment options.

Patient advocates also welcomed the decision. Brindley Brooks, founder and CEO of HS Connect, said the disease affects more than the skin, often impacting confidence, emotional well-being, and social relationships during adolescence. The new approval, she said, offers hope for earlier intervention and improved outcomes.

According to Victor Bultó, President of Novartis US, expanding Cosentyx to younger patients addresses a long-standing gap in HS care. He emphasized that the therapy’s distinct IL-17A mechanism provides physicians with a differentiated treatment option and enables dosing tailored to patient weight.

Cosentyx is a fully human monoclonal antibody that selectively inhibits interleukin-17A, a cytokine involved in inflammatory pathways across several immune-mediated diseases. The therapy has more than a decade of clinical and real-world experience and has been used to treat over 1.8 million patients globally since its launch in 2015.

Beyond hidradenitis suppurativa, Cosentyx is approved for multiple immune-mediated conditions, including plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis in adults, as well as certain pediatric inflammatory disorders. The drug is currently approved in more than 100 countries worldwide.

Hidradenitis suppurativa is estimated to affect roughly 1 in 100 people globally and is associated with significant comorbidities such as obesity, diabetes, arthritis, and depression. Diagnosis can be delayed for years, with patients often waiting up to a decade before receiving a correct diagnosis.

Reference

Novartis Cosentyx® receives FDA approval for pediatric patients aged 12+ with moderate to severe hidradenitis suppurativa, 13 March 2026, Novartis Cosentyx® receives FDA approval for pediatric patients aged 12+ with moderate to severe hidradenitis suppurativa | Novartis

This Was a Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects with Moderate to Severe Hidradenitis Suppurativa (HS). (SUNSHINE), ClinicalTrials.gov ID NCT03713619, https://clinicaltrials.gov/study/NCT03713619

Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS) (SUNRISE), ClinicalTrials.gov ID NCT03713632, https://clinicaltrials.gov/study/NCT03713632