FDA Expands Cosentyx Approval to Treat Hidradenitis Suppurativa in Adolescents

The Food and Drug Administration (FDA) has approved Cosentyx (secukinumab) for the treatment of moderate to severe hidradenitis suppurativa (HS) in adolescents aged 12 years and older, Novartis announced on March 13, 2026. This approval marks Cosentyx as the first interleukin-17A (IL-17A) inhibitor approved for a pediatric population with HS.

Understanding Hidradenitis Suppurativa

Hidradenitis suppurativa is a chronic autoinflammatory condition affecting approximately 1% to 4% of the population in the United States. The condition is characterized by painful, inflammatory lesions, often beginning in adolescence and can lead to irreversible scarring and disability.

Clinical Evidence Supporting the Approval

The approval for use in adolescents is supported by data from adult studies, pharmacokinetic modeling extrapolated from adult HS and psoriasis clinical trials, and pediatric clinical trial data from other approved indications. Dosing analysis indicated that weight-based dosing of secukinumab in pediatric patients can achieve similar exposure levels to those seen in adult HS patients, according to Novartis.

Expert Perspective

“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, president and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, and professor of dermatology at Harvard Medical School. “The approval of Cosentyx represents an important advancement for younger HS patients who have had limited treatment options.”

Lauren A. V. Orenstein, MD, MSc, Assistant Professor, Department of Dermatology, Emory University, and Staff physician, Grady Memorial Hospital, emphasized the importance of early intervention. “HS is a painful, stigmatizing disease that often emerges during adolescence — a period when early intervention may change the entire course of the condition. Having access to effective therapies during this window means we can act before the disease leaves lasting physical and psychological scars and give young patients greater hope for a life beyond HS.”

Previous Approvals and Background

The FDA initially approved secukinumab as the first IL-17A inhibitor for the treatment of HS in adults in 2023. Cosentyx has a well-established safety profile with over a decade of real-world experience across multiple autoimmune diseases.

Looking Ahead

The expansion of Cosentyx’s approval to include adolescents with HS addresses a significant unmet need in this patient population. This advancement offers hope for improved outcomes and quality of life for young people living with this challenging condition.