FDA Expands Secukinumab Approval to Patients 12 Years and Older With Hidradenitis Suppurativa

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 company announced.¹ The approval expands secukinumab’s pediatric indications to 4.

The approval was supported by analyses of data from the phase 3 SUNSHINE (NCT03713619) clinical trial and SUNRISE (NCT03713632) extension trial, in which secukinumab showed symptom improvements in adults with HS.² Pharmacokinetic modeling and dosing analyses were extrapolated from adult HS and psoriasis clinical trials, as well as from pediatric clinical trial data from other approved indications.¹

HS is a chronic, systemic inflammatory skin disease characterized by recurring boil-like abscesses that can rupture into open, painful wounds and result in permanent scarring.² The condition frequently emerges around the time of puberty, with more than half of patients developing symptoms during adolescence. Despite its significant impact on quality of life, diagnosis is often delayed, and available treatment options for younger patients have remained limited.

Secukinumab, an IL-17A inhibitor, targets the inflammation that underlies a range of immune-mediated inflammatory diseases, including HS.¹

“Hidradenitis suppurativa 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 and 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.”

Since its 2015 launch, secukinumab has been used to treat more than 1.8 million patients worldwide and is approved across indications, including adult HS, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and nonradiographic axial spondyloarthritis.^1,4 Its 4 current pediatric FDA approvals reflect an expanding evidence base across age groups.¹

"Hidradenitis suppurativa 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."

When secukinumab was first FDA approved for adults with HS based on SUNSHINE and SUNRISE study results, it became the second approved biologic to treat the condition.⁵ At 16 weeks, patients receiving 300 mg of secukinumab every 2 weeks or every 4 weeks were more likely to achieve a 50% decrease in abscess and inflammatory nodules based on Hidradenitis Suppurativa Clinical Response (HiSCR50) compared with patients receiving a placebo. The HiSCR50 values observed at 16 weeks also improved over time through 52 weeks.

The new indication adds a treatment option to a space where clinical need has outpaced available therapies for years. For patients and clinicians navigating HS in adolescent populations, the availability of a weight-based, IL-17A–targeted biologic with an established safety record may help support earlier, more tailored intervention.

“With more than a decade of real-world experience across multiple autoimmune diseases, [secukinumab] is a well-established treatment option that many physicians trust,” Victor Bultó, president of Novartis US, said.¹ “Yet for young people living with moderate to severe [HS], treatment options have remained limited for far too long. Expanding [secukinumab] 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. March 13, 2026. Accessed March 16, 2026. https://www.novartis.com/news/media-releases/novartis-cosentyx-receives-fda-approval-pediatric-patients-aged-12-moderate-severe-hidradenitis-suppurativa

2. Novartis Cosentyx shows clinically meaningful symptom improvements in patients with hidradenitis suppurativa in pivotal Phase III trials. News release. Novartis. September 10, 2022. Accessed March 16, 2026. https://www.novartis.com/news/media-releases/novartis-cosentyx-shows-clinically-meaningful-symptom-improvements-patients-hidradenitis-suppurativa-pivotal-phase-iii-trials

3. Ballard K, Sathe NC, Shuman VL. Hidradenitis suppurativa. In: StatPearls. StatPearls Publishing; May 6, 2024. Accessed March 16, 2026. https://www.ncbi.nlm.nih.gov/books/NBK534867/

4. Cosentyx. Prescribing information. Novartis; 2026. Accessed March 16, 2026. https://www.novartis.com/us-en/sites/novartis_us/files/cosentyx.pdf

5. Joszt L. Secukinumab gains FDA approval to treat hidradenitis suppurativa. AJMC^®. October 31, 2024. Accessed March 16, 2026. https://www.ajmc.com/view/secukinumab-gains-fda-approval-to-treat-hidradenitis-suppurativa