Novartis has announced that the U.S. Food and Drug Administration (FDA) has approved Cosentyx (secukinumab) for the treatment of pediatric patients aged 12 years and older with moderate to severe hidradenitis suppurativa (HS). The decision marks a significant expansion of treatment options for younger patients suffering from this chronic and often debilitating skin condition.
With this approval, Cosentyx becomes the only interleukin-17A (IL-17A) inhibitor available for adolescents with HS, offering a new biologic therapy option in a population where treatment choices have historically been limited. The move is expected to help physicians better tailor therapies to individual patient needs, particularly during a critical stage of physical and emotional development.
Hidradenitis suppurativa is a chronic inflammatory disease characterized by recurrent, painful, boil-like lesions that can rupture and lead to permanent scarring. The condition often begins during adolescence, with more than half of patients developing symptoms at a young age. Globally, HS is estimated to affect up to 1% of the population, underscoring the need for effective early interventions.
Medical experts have welcomed the approval as an important step forward. Dr. Alexa B. Kimball, a leading investigator in HS clinical trials, highlighted that the disease can cause irreversible damage if left untreated. She emphasized that introducing a biologic therapy like Cosentyx for younger patients represents meaningful progress in addressing unmet clinical needs.
Patient advocacy groups have also underscored the broader impact of HS beyond physical symptoms. Brindley Brooks, Founder and CEO of HS Connect, noted that the disease can significantly affect self-confidence, emotional well-being, and social relationships, particularly during adolescence. The availability of a new treatment option, she said, offers hope to families seeking earlier and more effective care.
The FDA’s decision is supported by data from well-controlled adult clinical trials, along with pharmacokinetic modeling and additional pediatric data from other approved uses of Cosentyx. These analyses demonstrated that weight-based dosing in pediatric patients can achieve drug exposure levels comparable to those seen in adults with HS, supporting its safety and efficacy profile.
Cosentyx has been used for over a decade in treating multiple autoimmune conditions, building a strong track record among healthcare providers. Novartis executives emphasized that expanding its use into pediatric HS aligns with the company’s commitment to addressing gaps in care and improving outcomes for underserved patient populations.
The approval represents a meaningful advancement in the management of hidradenitis suppurativa, particularly for adolescents who previously had few effective treatment options.