FDA Clears Secukinumab for Adolescents With Severe Chronic Skin Disease

In a significant milestone for adolescent dermatology, the FDA has approved secukinumab (Cosentyx; Novartis) for the treatment of pediatric patients 12 years and older with moderate to severe hidradenitis suppurativa (HS). The decision establishes secukinumab as the first and only IL-17A inhibitor approved for this specific younger population, filling a decade-long void in new therapeutic mechanisms for adolescents with HS.¹

A Challenging Road for Young Patients

HS is a chronic, systemic, and progressive inflammatory skin condition characterized by recurring, painful, boil-like lesions that can rupture into open wounds, often leading to irreversible scarring and physical disabilities. For many patients, HS emerges early—often around puberty—with more than half of all patients developing symptoms during their teenage years. Because the disease frequently affects intimate areas of the body, it has a heavy psychological burden.¹

HS “impacts confidence, emotional well-being, and relationships during a formative period,” according to Brindley Brooks, founder and CEO of HS Connect, in a news release from Novartis. Patients also often face a 10-year average delay to receive the correct diagnosis, during which time the disease can progress significantly.¹

Bridging the Critical Gap in Care

Until this approval, treatment options for adolescents with moderate to severe HS were notably limited. In the news release, Novartis US President Victor Bultó said younger patients have been underserved for “far too long,” adding that the expanded indication for secukinumab “addresses a critical gap in care.”¹

Secukinumab directly inhibits IL-17A, a key cytokine involved in the inflammation that drives HS and other immune-mediated diseases. The approval represents the fourth pediatric indication for secukinumab, which is already utilized for conditions such as plaque psoriasis and juvenile psoriatic arthritis.¹

Data Supporting the Approval

The FDA’s decision was bolstered by a robust clinical foundation, including the phase 3 SUNSHINE (NCT03713619) and SUNRISE (NCT03713632) clinical trials. These trials, which involved more than 1000 adult patients, demonstrated that secukinumab provided sustained efficacy and a favorable safety profile.

Patients treated with secukinumab showed significantly better clinical responses (measured by the Hidradenitis Suppurativa Clinical Response) compared to those on a placebo as early as week 16. The efficacy remained consistent regardless of whether patients had previously tried other biologic therapies or were biologic-naive.²

For the pediatric population, dosing is tailored to patient weight (specifically for those weighing 30 kg or more), a strategy supported by pharmacokinetic modeling that predicts similar drug exposure to that seen in successful adult trials.^1,2

“The approval of Cosentyx represents an important advancement for younger HS patients who have had limited treatment options,” said Alexa B. Kimball, MD, MPH, lead investigator of the SUNSHINE and SUNRISE clinical trials in adult patients with HS, and president and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, Boston, Massachusetts, in a news release.¹

Safety and Monitoring

As with all systemic biologic treatments, secukinumab has important safety considerations. Because the medication affects the immune system, it can increase the risk of serious infections, including tuberculosis and bacterial, fungal, or viral infections.¹

The most common adverse effects reported in clinical trials include cold symptoms, diarrhea, and upper respiratory tract infections. The FDA and Novartis also advise that patients be screened for tuberculosis before initiating treatment and monitored for new or worsening inflammatory bowel disease, as flare-ups can occur with this class of medications.^1,2

Looking Ahead

With more than 1.8 million patients treated worldwide since its initial launch in 2015, secukinumab is a well-established treatment in the immunology space. For the roughly 1 in 100 people globally affected by HS, this new approval offers a ray of hope for earlier intervention, potentially limiting the most severe, life-altering complications of the disease in younger patients.

REFERENCES

1. Novartis Cosentyx receives FDA approval for pediatric patients aged 12+ with moderate to severe hidradenitis suppurativa. News release. Novartis. March 13, 2026. Accessed 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. Zouboulis CC, Passeron T, Pariser D, et al. Secukinumab in patients with moderate-to-severe hidradenitis suppurativa based on prior biologic exposure: an efficacy and safety analysis from the SUNSHINE and SUNRISE phase III trials. Br J Dermatol. 2024;190(6):836-845. doi:10.1093/bjd/ljae098