The Food and Drug Administration has approved Cosentyx (secukinumab) for the treatment of adolescents aged 12 and older with moderate to severe hidradenitis suppurativa (HS), a chronic inflammatory skin condition. This marks the first time an IL-17A inhibitor has been approved for use in children with this debilitating disease, offering a new therapeutic option for a population that has historically faced limited treatment choices.
Hidradenitis suppurativa, affecting an estimated 1% to 4% of people in the United States, is characterized by painful, often deep-seated lesions that can lead to scarring and significantly impact quality of life. The condition frequently begins during adolescence, making early intervention crucial. The approval of Cosentyx addresses a critical unmet need for younger patients, according to Novartis, the manufacturer of the drug.
“Hidradenitis suppurativa often begins in adolescence and can cause irreversible scarring and disabilities,” said Alexa B. Kimball, MD, MPH, president and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center and professor of dermatology at Harvard Medical School, in a press release. “The approval of Cosentyx represents an vital advancement for younger HS patients who have had limited treatment options.”
How Cosentyx Works and Supporting Data
Cosentyx is an interleukin-17A (IL-17A) inhibitor, a type of medication that works by blocking a specific protein involved in the inflammatory process. The FDA’s decision to expand the use of Cosentyx to include adolescents is based on data from adult studies, pharmacokinetic modeling and pediatric clinical trial data from other approved indications, Novartis stated. Analysis of dosing regimens also indicated that weight-based dosing in pediatric patients is expected to achieve similar drug exposure levels as seen in adults with HS.
The FDA initially approved secukinumab as the first IL-17A inhibitor for the treatment of HS in adults in 2023. This latest approval builds upon that foundation, extending the benefits of this therapy to a younger patient population.
Impact on Patients and Future Directions
Victor Bultó, president of Novartis US, emphasized the significance of this expansion, stating, “With more than a decade of real-world experience across multiple autoimmune diseases, Cosentyx is a well-established treatment option that many physicians trust. Yet for young people living with moderate to severe hidradenitis suppurativa, 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.”
Lauren A. V. Orenstein, MD, MSc, Assistant Professor of Dermatology at Emory University and Staff Physician at Grady Memorial Hospital, noted the importance of early intervention in HS. “HS is a painful, stigmatizing disease that often emerges during adolescence — a period when early intervention may change the entire course of the condition. Having access to effective therapies during this window means we can act before the disease leaves lasting physical and psychological scars and offer young patients greater hope for a life beyond HS.” Dr. Orenstein has financial relationships with Incyte, Novartis, Pfizer, and UCB Pharma and is a member of the board of directors for the HS Foundation.
The approval of Cosentyx for pediatric HS represents a significant step forward in the management of this challenging condition. Further research will continue to refine treatment strategies and improve the lives of individuals living with HS.
Disclaimer: This article provides informational content and should not be considered medical advice. Always consult with a qualified healthcare professional for diagnosis and treatment of any medical condition.
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