The FDA has approved Novartis’s Cosentyx (secukinumab) for pediatric patients aged 12 and older with moderate to severe hidradenitis suppurativa, making it the only IL-17A inhibitor approved for this population. The approval marks the fourth pediatric indication for the drug, which has treated over 1.8 million patients since its 2015 launch.
Hidradenitis suppurativa is a chronic, systemic inflammatory skin disease affecting approximately 1 in 100 people worldwide, often beginning during adolescence. The condition causes recurring boil-like lesions that rupture into painful wounds, potentially leading to permanent scarring and significant quality-of-life impacts. Dr. Alexa B. Kimball noted the disease can cause “irreversible scarring and disabilities” when it begins in adolescence, while Brindley Brooks of HS Connect emphasized its effects on “confidence, emotional well-being and relationships during a formative period.”
The approval applies to patients weighing 30 kg or more and uses weight-based dosing tailored for pediatric patients. The decision was supported by adult clinical studies, pharmacokinetic modeling, and pediatric data from other approved indications. Cosentyx maintains approval across multiple immune-mediated conditions including psoriasis, arthritis, and ankylosing spondylitis.