FDA Approves Cosentyx for Pediatric Hidradenitis Suppurativa, Marking First IL-17A Inhibitor for Adolescents
核心洞察
The FDA approved Cosentyx (secukinumab) for treating pediatric patients aged 12 and older with moderate to severe hidradenitis suppurativa (搜索), making it the first IL-17A (搜索) inhibitor approved for this population.
More than half of hidradenitis suppurativa (搜索) patients develop symptoms during adolescence, highlighting the critical importance of early intervention with biologics to reduce long-term disease burden.
The approval is supported by well-controlled adult studies and pharmacokinetic modeling, with weight-based dosing predicted to provide similar drug exposure in pediatric patients as in adults.
The FDA has approved Cosentyx (secukinumab) for treating pediatric patients aged 12 years and older with moderate to severe hidradenitis suppurativa (搜索) (HS), marking a significant milestone as the first IL-17A (搜索) inhibitor approved for this population. The approval, announced by Novartis on March 13, 2026, addresses a critical treatment gap for younger patients living with this challenging inflammatory skin condition.
Addressing Early-Onset Disease
Hidradenitis suppurativa (搜索) often emerges around puberty, with more than half of patients developing symptoms during adolescence. The condition is a chronic, systemic inflammatory skin disease that causes recurring boil-like lesions, which can rupture into painful wounds and lead to irreversible scarring. HS affects as many as 1 in 100 people worldwide, with estimates suggesting it impacts approximately 1% to 4% of people in the United States.
"Hidradenitis suppurativa (搜索) often begins in adolescence and can cause irreversible scarring and disabilities," said Dr. Alexa B. Kimball, lead investigator of the SUNSHINE and SUNRISE clinical trials in adult HS patients, President and CEO of Harvard Medical Faculty Physicians (搜索) at Beth Israel Deaconess Medical Center, and Professor of Dermatology at Harvard Medical School. "The approval of Cosentyx represents an important advancement for younger HS patients who have had limited treatment options."
Clinical Evidence and Dosing Strategy
The approval is supported by well-controlled adult studies and pharmacokinetic modeling extrapolated from adult HS and psoriasis clinical trials, as well as pediatric clinical trial data from other approved indications. Dosing analysis predicted that weight-based dosing of Cosentyx in pediatric patients can provide similar exposure to adult HS patients, with the treatment indicated for patients weighing 30 kg or more.
Cosentyx is a fully human biologic that directly inhibits interleukin-17A (搜索), an important cytokine involved in the inflammation underlying multiple immune-mediated inflammatory diseases. The distinct IL-17A (搜索) mechanism provides physicians with a differentiated therapeutic option to help manage this challenging condition in younger patients, with dosing tailored to patient weight.
Broader Treatment Landscape
This approval marks the fourth pediatric indication for Cosentyx, reinforcing its robust safety and efficacy profile across multiple conditions. The drug is already approved for use in adults with hidradenitis suppurativa (搜索), psoriatic arthritis (搜索), moderate to severe plaque psoriasis (搜索), ankylosing spondylitis (搜索), and non-radiographic axial spondyloarthritis, as well as in pediatric patients with psoriasis, enthesitis-related arthritis (搜索), and juvenile psoriatic arthritis (搜索).
"With more than a decade of real-world experience across multiple autoimmune diseases, Cosentyx is a well-established treatment option that many physicians trust," said Victor Bultó, President of Novartis US. "Yet for young people living with moderate to severe hidradenitis suppurativa (搜索), treatment options have remained limited for far too long. Expanding Cosentyx to this population addresses a critical gap in care and underscores our focus on advancing solutions where we can make the greatest impact on outcomes."
Patient Impact and Disease Burden
The condition significantly impacts patients' quality of life more than any other skin disease, and people living with HS often experience comorbidities such as obesity, diabetes, arthritis and depression. It can take up to 10 years on average to get a correct diagnosis, highlighting the importance of early recognition and intervention.
"Hidradenitis suppurativa (搜索) affects far more than skin; it impacts confidence, emotional well-being and relationships during a formative period for many pediatric patients," said Brindley Brooks, Founder & CEO of HS Connect (搜索). "For families watching their children struggle, this FDA approval brings hope for earlier intervention."
Since its launch in 2015, Cosentyx has been used to treat more than 1.8 million patients worldwide and is now approved in over 100 countries. The drug is supported by robust evidence and more than 10 years of real-world data demonstrating its long-term safety and sustained efficacy across multiple indications.