FDA Approves Secukinumab for Younger Hidradenitis Suppurativa Patients

March 16, 2026 Ananya Mittal - World Editor

The Food and Drug Administration (FDA) has expanded the approval of Cosentyx (secukinumab) to include treatment for pediatric patients aged 12 years and older with moderate to severe hidradenitis suppurativa (HS). This marks the first time an IL-17A inhibitor has been approved for this age group, and represents a significant step forward in addressing a condition that often begins around the time of puberty. Novartis, the manufacturer of Cosentyx, announced the approval on March 13, 2026.

Understanding Hidradenitis Suppurativa

Hidradenitis suppurativa is a chronic, inflammatory skin disease characterized by recurring boil-like lesions in areas where skin rubs together, such as the armpits, groin, and under the breasts. These lesions can be painful, rupture, and lead to scarring. It affects as many as 1 in 100 people worldwide, and often first appears during adolescence, making early diagnosis and intervention particularly essential. The condition is systemic, meaning it affects the whole body, not just the skin.

The impact of HS extends beyond physical discomfort. The chronic inflammation and potential for scarring can significantly affect quality of life, leading to emotional distress and disability. Because it often emerges around puberty, the psychological and social consequences for young people can be especially profound.

Cosentyx: How it Works and What the Approval Means

Cosentyx is a biologic medication that works by targeting interleukin-17A (IL-17A), a protein that plays a key role in inflammation. By blocking IL-17A, Cosentyx helps to reduce the inflammatory processes that drive the symptoms of HS. It is now the only IL-17A inhibitor approved for treating HS in patients 12 years and older. The approval is likewise notable as the first new mechanism of action for treating HS in nearly a decade.

This expanded approval addresses a critical gap in treatment options for adolescents and young adults living with HS. Previously, treatment options were limited, and often involved managing symptoms rather than addressing the underlying inflammatory process. The availability of a targeted biologic therapy like Cosentyx offers the potential for more effective disease control and improved long-term outcomes.

Clinical Trial Insights and Limitations

While the FDA approval is based on clinical trial data, it’s important to understand the context of that data. The approval for pediatric patients was supported by data from trials conducted in adult HS patients, led by investigators like Alexa B. Kimball, MD, MPH, of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center. These trials, known as SUNSHINE and SUNRISE, demonstrated the efficacy and safety of Cosentyx in adults.

However, it’s crucial to note that the data specifically addressing the employ of Cosentyx in 12-year-olds and older is extrapolated from adult trials. While What we have is a common practice in drug development, it means that the specific response and safety profile in pediatric patients may differ. Further research specifically focused on pediatric HS patients will be important to confirm these findings and refine treatment strategies.

What This Means for Patients and Clinicians

The FDA’s decision provides clinicians with a new tool to manage moderate to severe HS in adolescent patients. It allows for a more tailored approach to treatment, recognizing that HS often begins during adolescence and requires early intervention to reduce the long-term disease burden. The availability of a distinct biologic option, like Cosentyx, expands the treatment landscape and offers hope for improved outcomes.

For patients and families, this approval signifies increased awareness and recognition of HS as a serious condition affecting young people. It underscores the importance of seeking early diagnosis and treatment from a qualified dermatologist. It’s important to remember that HS is a complex condition, and treatment decisions should be made in consultation with a healthcare professional, considering individual patient factors and preferences.

Navigating the Treatment Landscape

HS treatment often involves a multi-faceted approach, combining medications, lifestyle modifications, and, in some cases, surgical interventions. Topical treatments, antibiotics, and other systemic medications may be used to manage symptoms. However, for patients with moderate to severe HS, biologic therapies like Cosentyx offer a more targeted approach to address the underlying inflammation.

The FDA’s label for Cosentyx currently indicates its approval for treating moderate to severe HS in adults, as well as now in pediatric patients 12 years and older. It is essential for healthcare providers to carefully evaluate each patient’s individual circumstances and determine the most appropriate treatment plan.

Future Directions and Ongoing Research

The approval of Cosentyx for pediatric HS patients is a significant milestone, but it is not the end of the story. Ongoing research is crucial to further refine our understanding of HS, identify new treatment targets, and improve outcomes for patients of all ages. Future studies may focus on:

  • Evaluating the long-term safety and efficacy of Cosentyx in pediatric patients.
  • Identifying biomarkers that can predict treatment response.
  • Developing new therapies that target different pathways involved in HS pathogenesis.

As research progresses, and as more data become available, treatment guidelines and recommendations may evolve. Patients and healthcare providers should stay informed about the latest developments in HS management by consulting reputable sources and participating in ongoing clinical trials when appropriate.