Reflecting on FDA Approval of Secukinumab for HS in Children, With Alexa Kimball, MD, MPH

On March 13, the US Food and Drug Administration (FDA) approved secukinumab for patients with moderate to severe hidradenitis suppurativa (HS), specifically those aged 12 years and older.1,2

This approval, positioning secukinumab as the only interleukin (IL)-17A inhibitor currently indicated for this population, made this the first differentiated mechanism in nearly a decade. In light of the FDA’s addition of this biologic option to the limited agents available in the pediatric HS armamentarium, the HCPLive team interviewed Alexa Kimball, MD, MPH.

Kimball, the president and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center and professor of dermatology at Harvard Medical School, was an investigator on the trial program leading up to this approval. The following Q&A transcribes her responses to HCPLive:

HCPLive: This approval marks the first new mechanism in pediatric HS in nearly a decade, and only the second approved treatment option for this population overall. How significant is that from a clinical standpoint?

Kimball: Studies suggest that initiating treatment early in the HS disease course is associated with higher responsiveness to treatment. This advantage is consistent with what I have experienced with the patients I treat. Intervening before scars and tunnels develop is a clear clinical goal for our patients

HCPLive: The label is supported by a combination of adult HS trial data, pharmacokinetic modeling, and pediatric data extrapolated from other indications. Can you walk us through why that evidentiary approach was appropriate here, and how confident you are in the weight-based dosing regimen?

Kimball: I defer to the FDA on this question. It does appear that the methodology used here is consistent with how other similar approvals have been evaluated.

HCPLive: HS in adolescence carries a particularly heavy psychosocial burden. Did you see meaningful quality-of-life improvements in younger patients alongside the clinical endpoints, and how do you weigh those outcomes when evaluating a therapy for this age group?

Kimball: We would need specific studies to determine the answer to your question above. There is a concept increasingly accepted across dermatology emphasizing that early treatment for chronic dermatologic diseases is important because success can alter important trajectories such as education, employment and relationships. That concept, Cumulative Life Course Impairment, would further support the important of early treatment.

HCPLive: Secukinumab already carries more than a decade of real-world safety data. How much does that established track record factor into your comfort level prescribing it to a pediatric population, and are there any monitoring considerations specific to adolescents that clinicians should keep in mind?

Kimball: Working with medications with established safety profiles is always reassuring. There isn’t any monitoring I would do differently in adolescents than in adults.

Kimball’s institution received grants from Abbvie, Admirx, Anapyts Bio, Aristea, Bristol Myers Squibb, Chemocentryx, Eli Lilly, Incyte, Janssen, Moonlake, Novartis, Pfizer, Prometheus, UCB; Sonoma Bio. Kimball received consulting fees from Abbvie, Alumis, Bayer, Bristol Myers Squibb, Boehringer Ingelheim, Eli Lilly, Janssen, Moonlake Novartis, Pfizer, Priovant, Sonoma Bio, Sanofi, UCB; Target RWE, Ventyx; and serves on the board of directors of Almirall.

References

1. Smith T. FDA Approves Secukinumab for Pediatric Patients 12 Years and Older with HS. HCPLive. March 13, 2026. Accessed March 18, 2026. https://www.hcplive.com/view/fda-approves-secukinumab-for-pediatric-patients-12-years-older-hs.

2. Novartis Cosentyx® receives FDA approval for pediatric patients aged 12+ with moderate to severe hidradenitis suppurativa. Novartis. March 13, 2026. Accessed March 18, 2026. https://www.novartis.com/us-en/news/media-releases/novartis-cosentyx-receives-fda-approval-pediatric-patients-aged-12-moderate-severe-hidradenitis-suppurativa.