FDA approves Cosentyx for pediatric hidradenitis suppurativa

The FDA has approved Novartis’s Cosentyx (secukinumab) for the treatment of moderate to severe hidradenitis suppurativa in pediatric patients 12 years and older, according to a news release published today.

The approval makes Cosentyx the only interleukin-17A (IL-17A) inhibitor approved for this patient population and introduces the first differentiated mechanism of action for hidradenitis suppurativa in nearly a decade. Interleukin-17A is a cytokine that plays a central role in inflammatory pathways associated with several immune-mediated diseases. By blocking IL-17A, the therapy helps reduce the inflammatory activity believed to drive hidradenitis suppurativa lesions and symptoms.

Hidradenitis suppurativa is a chronic, systemic inflammatory condition characterized by painful nodules, abscesses and draining tunnels that typically occur in areas where skin rubs together, such as the armpits, groin and under the breasts. It occurs in approximately 1 in 100 people globally, sometimes taking up to 10 years to get a correct diagnosis.

“With more than a decade of real-world experience across multiple autoimmune diseases, Cosentyx is a well-established treatment option that many physicians trust,” Victor Bultó, president, Novartis US, said in the news release. “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.”

Hidradenitis suppurativa often develops during adolescence, with many patients first experiencing symptoms around puberty, making early treatment particularly important.

“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, HS Connect, said in the news release. “For families watching their children struggle, this FDA approval brings hope for earlier intervention.”

The disease impacts patients' quality of life more than any other skin disease because it is often comorbid with obesity, diabetes and arthritis. Additionally, approximately 43% of hidradenitis suppurativa patients report depression.

The newly approved indication allows Cosentyx to be used in pediatric patients aged 12 years and older who weigh at least 60 lbs. Dosing is based on patient weight to help achieve drug exposure similar to that seen in adults with hidradenitis suppurativa.

The phase 3 SUNSHINE and SUNRISE trials in adults with moderate to severe hidradenitis suppurativa provide clinical evidence for the use of Cosentyx. In those studies, significantly more patients treated with Cosentyx achieved a clinical response compared with placebo, including reductions in inflammatory lesions such as abscesses and draining tunnels.

The biologic therapy already has several FDA-approved indications across dermatology and rheumatology. These include plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, nonradiographic axial spondyloarthritis and hidradenitis suppurativa in adults, as well as certain pediatric autoimmune conditions. It was originally approved in 2015 for moderate-to-severe plaque psoriasis. The FDA first approved it in 2023 for adults with hidradenitis suppurativa.

The approval for pediatric hidradenitis suppurativa is the fourth time Cosentyx has been approved for use in children, which broadens the drug’s application for

“Hidradenitis suppurativa often begins in adolescence and can cause irreversible scarring and disabilities," Alexa B. Kimball, M.D., M.P.H., 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, Boston, and professor of dermatology at Harvard Medical School, said in the news release. “The approval of Cosentyx represents an important advancement for younger HS patients who have had limited treatment options.”