BASEL, Switzerland, March 13, 2026
Global pharmaceutical leader 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 regulatory milestone expands access to a targeted biologic therapy for adolescents living with this chronic inflammatory skin disease, marking an important advancement in dermatology and immunology care. The approval establishes Cosentyx as the only IL-17A inhibitor authorized for pediatric HS patients, offering physicians a differentiated treatment option aimed at controlling inflammation and improving long-term patient outcomes.
FDA Approval Expands Treatment Options for Pediatric HS
Hidradenitis suppurativa is a chronic, progressive inflammatory skin disorder characterized by painful nodules, abscesses, and scarring, typically occurring in sensitive areas such as the underarms and groin. The disease often begins during adolescence, making early diagnosis and effective treatment essential to preventing long-term complications and improving quality of life.
The FDA approval allows Cosentyx to be prescribed for pediatric patients aged 12 years and older weighing at least 30 kilograms who suffer from moderate to severe HS. Until now, treatment options for adolescents with the condition have been limited, leaving many patients dependent on symptomatic therapies that do not address the underlying inflammatory pathways.
Cosentyx works by selectively inhibiting interleukin-17A (IL-17A), a key cytokine involved in inflammatory and immune-mediated diseases. By targeting this pathway, the therapy helps reduce inflammation, decrease lesion formation, and prevent disease progression. Experts believe this mechanism provides a significant advancement in biologic treatment strategies for HS, particularly in younger patients who require early intervention to prevent irreversible skin damage.
Advertisement
Clinical Evidence Supports Pediatric Use of Cosentyx
The pediatric approval is supported by clinical evidence from adult hidradenitis suppurativa trials combined with pharmacokinetic modeling and pediatric data from other approved indications of Cosentyx. Researchers demonstrated that weight-based dosing in adolescents can provide drug exposure levels comparable to those observed in adult HS patients, ensuring therapeutic effectiveness while maintaining a favorable safety profile.
Clinical studies evaluating Cosentyx in inflammatory diseases have consistently shown sustained efficacy and long-term safety, supporting its use across multiple immune-mediated conditions. Since its introduction in 2015, the therapy has been administered to more than 1.8 million patients worldwide, highlighting its extensive real-world clinical experience and trusted safety profile among healthcare providers.
Cosentyx is already approved for treating several immune-mediated diseases, including plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis. The latest pediatric approval represents the fourth pediatric indication for the biologic therapy, further reinforcing its role as a cornerstone treatment in inflammatory disease management.
Addressing a Significant Unmet Medical Need
Hidradenitis suppurativa affects approximately one in every 100 people globally, and the disease is associated with substantial physical and psychological burden. Patients often experience chronic pain, scarring, reduced mobility, and emotional distress, which can significantly impact daily activities and social interactions.
Because symptoms frequently appear during adolescence, early treatment with targeted biologic therapies may help slow disease progression and reduce long-term complications. Dermatology specialists emphasize that expanding access to biologic treatments for younger patients is critical to improving disease management and preventing permanent tissue damage.
With the FDA approval of Cosentyx for pediatric HS, Novartis continues to strengthen its leadership in immunology and dermatology therapeutics, focusing on innovative medicines that address complex inflammatory diseases. The company’s broader strategy centers on leveraging advanced biologic technologies to deliver targeted therapies capable of transforming patient care across multiple immune-mediated conditions.
As research continues to advance in immunology and dermatology, biologic therapies such as Cosentyx are expected to play an increasingly important role in managing chronic inflammatory diseases, offering new hope to patients who previously had limited treatment options. The approval of this pediatric indication therefore represents a significant step forward in improving outcomes for adolescents living with hidradenitis suppurativa worldwide.
Source: Novartis press release
