FDA expands secukinumab approval in hidradenitis suppurativa to 12 years and older

The FDA has approved secukinumab (Cosentyx) for the treatment of moderate to severe hidradenitis suppurativa (HS) in pediatric patients 12 years and older, according to an announcement from Novartis on March 13, 2026.

The approval makes secukinumab the only interleukin (IL)–17A inhibitor indicated for this population. This marks the fourth pediatric indication for the agent and extends the biologic option to an age group with limited systemic treatment options 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 (NCT03713619) and SUNRISE (NCT03713632) clinical trials in adult HS patients, president and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, Boston, Massachusetts, and a professor of dermatology at Harvard Medical School. “The approval of secukinumab represents an important advancement for younger HS patients who have had limited treatment options.”

Early-Onset Disease Underscores the Unmet Need

HS is a chronic, systemic inflammatory skin disease that causes recurring boil-like lesions, which can rupture into painful wounds and lead to scarring, and affects as many as 1 in 100 people worldwide, often beginning around puberty. More than half of patients develop symptoms during adolescence, highlighting the importance of early intervention.

A 2021 cohort study published in JAMA Dermatology underscores why that early window matters. Among 1094 pediatric patients with HS drawn from a national insurance claims database, the mean age of symptom onset was 14.3 years, and children were far more likely than adults to pass through the emergency department and urgent care before receiving a correct diagnosis.

Pediatric patients were most commonly seen by pediatricians (81.7%) and family medicine physicians (66.5%) before diagnosis, with more than a third routing through emergency or urgent care, which highlights ongoing gaps in recognition at the primary care level.

Before the approval, adalimumab was the only biologic with an FDA indication for pediatric HS patients. The new secukinumab approval marks the first differentiated mechanism of action available in nearly a decade for this population.

Established Phase 3 Data

The adult indication for secukinumab in moderate to severe HS was granted in October 2023, supported by findings from the phase 3 SUNSHINE and SUNRISE trials. In those trials, a higher proportion of patients given secukinumab 300 mg every 2 or 4 weeks achieved Hidradenitis Suppurativa Clinical Response, defined as at least a 50% decrease in abscess and inflammatory nodule count with no increase in abscesses or draining tunnels compared with placebo. In both trials, onset of action was observed as early as week 2.

Secukinumab is a fully human monoclonal antibody that directly inhibits IL-17A, a cytokine implicated in the inflammatory cascade underlying HS and several other immune-mediated conditions. The agent has an established safety profile over more than a decade of use, spanning 6 approved indications in adult and pediatric populations.

“With more than a decade of real-world experience across multiple autoimmune diseases, Cosentyx is a well-established treatment option that many physicians trust,” said Victor Bultó, president, Novartis US. “Yet for young people living with moderate to severe hidradenitis suppurativa, treatment options have remained limited for far too long. Expanding Cosentyx to this population addresses a critical gap in care and underscores our focus on advancing solutions where we can make the greatest impact on outcomes.”

References

1. Novartis Cosentyx receives FDA approval for pediatric patients aged 12+ with moderate to severe hidradenitis suppurativa. News release. Novartis. Accessed March 13, 2026. http://novartis.com/news/media-releases/novartis-cosentyx-receives-fda-approval-pediatric-patients-aged-12-moderate-severe-hidradenitis-suppurativa

2. FDA approves Novartis Cosentyx as the first new biologic treatment option for hidradenitis suppurativa patients in nearly a decade. News release. Novartis. October 31, 2023. Accessed March 13, 2026. https://www.novartis.com/news/media-releases/fda-approves-novartis-cosentyx-first-new-biologic-treatment-option-hidradenitis-suppurativa-patients-nearly-decade

3. Hallock KK, Mizerak MR, Dempsey A, Maczuga S, Kirby JS. Differences between children and adults with hidradenitis suppurativa. JAMA Dermatol. 2021;157(9):1095–1101. doi:10.1001/jamadermatol.2021.2865