Global pharma giant Novartis has announced that its Cosentyx (secukinumab) has received FDA approval for treating pediatric patients aged 12 and older with moderate to severe hidradenitis suppurativa (HS), making it the only IL-17A inhibitor approved for this young population. 

 

The approval provides a distinct biologic option, allowing treatment to be tailored to individual patients and positioning Cosentyx as a meaningful addition to the HS treatment landscape.

 

“Hidradenitis suppurativa (HS) often begins in adolescence and can cause irreversible scarring and disabilities,” said Alexa B Kimball, 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. 

 

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

 

HS is a chronic, systemic inflammatory skin disease that triggers recurring boil-like lesions, which can rupture into painful wounds and cause scarring. Affecting as many as 1 in 100 people worldwide, HS often starts around puberty, with more than half of patients showing symptoms during adolescence — highlighting the need for early intervention.

 

“Hidradenitis suppurativa (HS) affects far more than skin; it impacts confidence, emotional well-being and relationships during a formative period for many pediatric patients,” said Brindley Brooks, Founder & CEO of HS Connect. “For families watching their children struggle, this FDA approval brings hope for earlier intervention.”

 

Cosentyx’s IL-17A mechanism offers physicians a differentiated treatment option for younger patients, with dosing tailored to weight. The FDA approval for patients aged 12+ weighing 30 kg or more is supported by adult HS studies, pharmacokinetic modeling, and pediatric data from other approved indications. Weight-based dosing in pediatric patients is predicted to provide exposure comparable to adult HS patients.

 

“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 (HS), 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.”