FDA Expands Secukinumab to Adolescents With Moderate to Severe HS

Key Takeaways

• The FDA has approved secukinumab for patients aged 12 years and older with moderate to severe hidradenitis suppurativa (HS).

• Novartis says the expanded indication is supported by adult HS studies, pharmacokinetic modeling, and pediatric data from other approved secukinumab indications.

• The company said the decision adds a biologic option for adolescents with HS, which can lead to substantial scarring and psychosocial burden in teen patients.

The US Food and Drug Administrationv (FDA) has approved secukinumab (Cosentyx, Novartis) for pediatric patients aged 12 years and older with moderate to severe hidradenitis suppurativa (HS), becoming the only IL-17A inhibitor approved for this group, according to a press release from the manufacturer.

Novartis said the pediatric approval is supported by adequate and well-controlled adult HS studies, pharmacokinetic modeling from adult HS and psoriasis programs, and pediatric clinical data from other approved secukinumab indications. The company also said weight-based dosing in patients weighing at least 30 kg is expected to achieve drug exposure comparable to that seen in adults with HS. Current prescribing information for Cosentyx reflects the expanded pediatric HS indication.

“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 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, in the news release. “The approval of Cosentyx represents an important advancement for younger HS patients who have had limited treatment options.” 

Source: Novartis release, March 13, 2026