Novartis’ Cosentyx (secukinumab) has received US FDA approval to treat paediatric patients aged 12 years and older with moderate-to-severe hidradenitis suppurativa (HS), making it the only IL-17A inhibitor for this population.

Cosentyx is a fully human biologic that is also approved to treat paediatric patients with PsO, enthesitis-related arthritis (ERA), and juvenile psoriatic arthritis (JPsA). 

Affecting as many as 1% of the worldwide population, HS is a chronic, systemic inflammatory skin disease. The condition causes recurring boil-like lesions, which can lead to scarring. 

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

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

By tailoring dosing to patient weight, Cosentyx could help physicians manage HS in younger patients by providing a differentiated therapeutic option. 

Brindley Brooks, Founder & CEO, HS Connect, said: “Hidradenitis suppurativa affects far more than skin; it impacts confidence, emotional well-being and relationships during a formative period for many paediatric patients.”

“For families watching their children struggle, this FDA approval brings hope for earlier intervention.”

Data from adult studies and pharmacokinetic modelling taken from adult HS and psoriasis clinical trials, and paediatric clinical trial data from other approved indications, supports the use of Cosentyx in HS patients 12 years and over who weigh 30kg or more.

The FDA approval was also supported by dosing analysis, which predicted the weight-based dosing of Cosentyx can provide paediatric patients with similar exposure to adult HS patients.