FDA Expands Approval of Secukinumab to Include Patients 12 and Older With Hidradenitis Suppurativa

The FDA expanded the approval of Novartis’s secukinumab (Cosentyx) for pediatric patients 12 years and older with moderate-to-severe hidradenitis suppurativa (HS). This decision establishes secukinumab as the only IL-17A inhibitor approved for this specific population and addresses a significant clinical gap, as HS often emerges around puberty, yet younger patients have historically faced a scarcity of differentiated biologic treatments.¹

“Hidradenitis suppurativa (HS) often begins in adolescence and can cause irreversible scarring and disabilities,” Alexa B. Kimball, MD, MPH, president and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center in Boston, Massachusetts, and professor of dermatology at Harvard Medical School, said in a news release.¹ “The approval of Cosentyx represents an important advancement for younger HS patients who have had limited treatment options.”

The approval was based on 2 phase 3 clinical trials, SUNSHINE (NCT03713619) and SUNRISE (NCT03713632), which examined secukinumab at Week 16, based on Hidradenitis Suppurativa Clinical Response rates compared with the placebo. Further, investigators analyzed the maintenance of efficacy of secukinumab at Week 52 in patients with moderate to severe HS.^2,3

The data included pharmacokinetic modeling extrapolated from successful adult trials and data from other pediatric indications. This monoclonal antibody works by inhibiting IL-17A, a key cytokine involved in the inflammatory processes underlying HS and other immune-mediated diseases. For pediatric patients weighing 30 kg or more, dosing is tailored to the individual's weight, which clinical analysis predicts will provide drug exposure similar to that seen in adult patients. This weight-based approach allows health care providers to more precisely manage a condition that often causes significant physical disability and psychological distress during a formative period of life.^1,4

Pharmacists play a pivotal role in the initiation and management of secukinumab therapy, particularly regarding safety screening and patient counseling. Before starting treatment, patients must be tested for tuberculosis, as the medication can increase the risk of infections.⁴

Furthermore, pharmacists should be aware of the medication's contraindications and warnings, such as its potential to exacerbate inflammatory bowel diseases such as Crohn disease or ulcerative colitis. Patients and caregivers should also be advised to avoid live virus vaccines while on therapy and to report any signs of infection, such as fever or sores that do not heal, to their care team immediately.⁴

This regulatory milestone marks the fourth pediatric indication for secukinumab, reinforcing its established safety profile within the pediatric population. With HS affecting approximately 1 in 100 people worldwide and symptoms appearing in adolescence for more than half of those diagnosed, early intervention is vital to mitigate long-term disease burden and prevent permanent skin damage. By providing a differentiated therapeutic mechanism for younger patients, this approval offers a new path for managing a challenging disease that has long outpaced the available pediatric treatment arsenal.¹

“With more than a decade of real-world experience across multiple autoimmune diseases, Cosentyx is a well-established treatment option that many physicians trust,” Victor Bultó, president of Novartis US, said in the news release.¹ “Yet for young people living with moderate to severe HS, 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.”

Hidradenitis suppurativa, also known as acne inversa, is a chronic and progressive systemic inflammatory disease that manifests as painful, pea-sized lumps under the skin. These lesions typically develop in areas where skin rubs together, such as the armpits, groin, and buttocks.⁵

For pharmacists, understanding the severity of this condition is critical, as the disease can lead to the formation of tunnels under the skin, persistent drainage of malodorous pus, and irreversible scarring. Beyond physical symptoms, the disease is associated with significant comorbidities, including obesity, diabetes, and depression, and it impacts a patient's quality of life more severely than many other dermatological conditions.⁵

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REFERENCES

1. Novartis Cosentyx receives FDA approval for pediatric patients aged 12+ with moderate to severe hidradenitis suppurativa. News release. Novartis. March 13, 2026. Accessed March 16, 2026. https://www.novartis.com/news/media-releases/novartis-cosentyx-receives-fda-approval-pediatric-patients-aged-12-moderate-severe-hidradenitis-suppurativa

2. This Was a Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS) (SUNSHINE). ClinicalTrials.gov identification: NCT03713619. October 9, 2024. Accessed March 16, 2026. https://clinicaltrials.gov/study/NCT03713619

3. Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS) (SUNRISE). ClinicalTrials.gov identification: NCT03713632. October 9, 2024. Accessed March 16, 2026. https://clinicaltrials.gov/study/NCT03713632

4. Cleveland Clinic. Secukinumab injection. 2026. Accessed March 16, 2026. https://my.clevelandclinic.org/health/drugs/20859-secukinumab-injection

5. Mayo Clinic. Hidradenitis suppurativa. March 21, 2025. Accessed March 16, 2026. https://www.mayoclinic.org/diseases-conditions/hidradenitis-suppurativa/symptoms-causes/syc-20352306