Novartis (NYSE: NVS) announced that Cosentyx (secukinumab) received U.S. FDA approval for treating pediatric patients aged 12 years and older with moderate to severe hidradenitis suppurativa (HS), making it the only IL-17A inhibitor approved for this population. The approval, supported by well-controlled adult studies, pharmacokinetic modeling, and pediatric data from other indications, enables weight-based dosing that provides similar exposure to adult HS patients. The expansion reinforces Cosentyx’s dominant IL-17A franchise across dermatology and rheumatology indications in both adult and pediatric populations.
Regulatory Milestone
Item
Detail
Agency
U.S. Food and Drug Administration (FDA)
Approval Type
Pediatric indication expansion
Product
Cosentyx (secukinumab)
Drug Class
Fully human IL-17A inhibitor (biologic)
New Indication
Moderate to severe hidradenitis suppurativa (HS) – pediatric patients ≥12 years
Weight Requirement
≥30 kg
Supportive Data
Adult HS studies; PK modeling; pediatric data from other approved indications
Dosing Approach
Weight-based dosing for similar exposure to adult HS patients
EMA pediatric indication filing; harmonized label with U.S.
Younger Pediatric Study
2026-2028
Potential <12 years HS development; psoriasis experience supports feasibility
Combination Studies
Ongoing
Cosentyx + antibiotics or hormonal therapy in refractory HS
Forward‑Looking Statements This brief contains forward‑looking statements regarding commercial launch performance, global regulatory expansion, and competitive positioning for Cosentyx in pediatric hidradenitis suppurativa. Actual results may differ due to physician adoption rates, pricing negotiations, and competitive dynamics with TNF inhibitors.-Fineline Info & Tech
By Fineline Cube 