Novartis has received FDA approval for Cosentyx (secukinumab) to treat pediatric patients aged 12 years and older with moderate to severe hidradenitis suppurativa (HS). The decision makes Cosentyx the first IL‑17A inhibitor authorized for this adolescent HS population.
HS is a chronic inflammatory skin disease characterized by recurrent, boil-like lesions that can rupture, cause painful wounds, and lead to scarring. The condition often begins around puberty, and more than half of patients are reported to develop symptoms during adolescence, which has driven interest in earlier diagnosis and treatment with biologic therapies.
The newly approved pediatric use is supported by data from controlled adult HS studies, pharmacokinetic modeling based on adult HS and psoriasis trials, and pediatric clinical data from other approved Cosentyx indications. Dosing for adolescents with HS is weight-based, with guidance provided for patients weighing 30 kg or more.
This approval is the fourth pediatric indication for Cosentyx in the US and extends the drug’s use beyond its existing autoimmune and inflammatory disease indications. Novartis stated that expanding access to biologic therapy for younger HS patients is intended to address a longstanding gap in treatment options.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!