FDA Expands Cosentyx Approval: A Fresh Hope for Young People with Hidradenitis Suppurativa
The FDA has approved secukinumab (Cosentyx) for adolescents aged 12 years and older with moderate to severe hidradenitis suppurativa (HS), marking a significant step forward in the treatment of this chronic autoinflammatory condition. This approval makes Cosentyx the first IL-17A inhibitor authorized for apply in a pediatric population battling HS.
Understanding Hidradenitis Suppurativa
HS is a painful, chronic condition affecting approximately 1% to 4% of the population in the United States. Characterized by painful lesions, it often begins during adolescence, leading to potential irreversible scarring and disability. The condition can be difficult to diagnose and treat, significantly impacting quality of life.
Why This Approval Matters
Historically, treatment options for HS, particularly in younger patients, have been limited. “Hidradenitis suppurativa often begins in adolescence and can cause irreversible scarring and disabilities,” stated Alexa B. Kimball, MD, MPH, lead investigator of the SUNSHINE and SUNRISE clinical trials. “The approval of Cosentyx represents an critical advancement for younger HS patients who have had limited treatment options.”
Data Supporting the Expansion
The approval is based on data extrapolated from well-controlled adult studies and pharmacokinetic modeling from adult HS and psoriasis clinical trials. Pediatric clinical trial data from other approved indications contributed to the decision. Analysis confirmed that weight-based dosing in pediatric patients is expected to provide similar drug exposure levels as observed in adult HS patients.
The Role of IL-17A Inhibitors
IL-17A inhibitors, like secukinumab, target a specific protein involved in the inflammatory process. By blocking this protein, these medications can reduce the inflammation and pain associated with HS. Cosentyx was initially approved by the FDA as the first IL-17A inhibitor for the treatment of HS in adults in 2023.
Industry Response and Future Outlook
Victor Bultó, president of Novartis US, emphasized the importance of this expansion, stating, “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 You can create the greatest impact on outcomes.”
The FDA’s approval of secukinumab for adolescents with hidradenitis suppurativa is exciting news and hopefully a sign of more to reach for this underserved population. 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 give young patients greater hope for a life beyond HS.
Lauren A. V. Orenstein, MD, MSc
Disclosures: Orenstein reports financial relationships with Incyte, Novartis, Pfizer and UCB Pharma and is a member of the board of directors for the HS Foundation.
Frequently Asked Questions
- What is hidradenitis suppurativa? HS is a chronic inflammatory skin condition that causes painful bumps and lesions, typically in areas where skin rubs together.
- Who is eligible for Cosentyx treatment? The FDA has approved Cosentyx for adolescents 12 years and older with moderate to severe HS.
- How does Cosentyx work? Cosentyx is an IL-17A inhibitor, meaning it blocks a protein that contributes to inflammation.
- What were the key factors in the FDA’s approval? The approval was supported by data from adult studies, pharmacokinetic modeling, and pediatric clinical trial data.
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