FDA
FDA expands Cosentyx indication to include adolescents with hidradenitis suppurativa
On March 13, 2026, FDA expanded the Cosentyx (secukinumab) indication for moderate-to-severe hidradenitis suppurativa (HS) to include pediatric patients 12 years of age and older. Previously, it was approved for use in adult patients with this condition.
Efficacy
Approval of the expanded indication is supported by safety and efficacy data from adequate, randomized, double-blind, placebo-controlled trials (SUNSHINE [NCT03713619] and SUNRISE [NCT03713632]) in adult subjects (N=1,084) with moderate-to-severe HS. Additional supporting evidence includes population pharmacokinetic (PK) modeling and simulation based on data from adult subjects with plaque psoriasis (PsO) and HS, as well as pediatric subjects with PsO. Safety data from clinical trials in pediatric subjects with PsO and juvenile idiopathic arthritis (including juvenile psoriatic arthritis and enthesitis-related arthritis) were also considered.
PK modeling and simulation predict that Cosentyx concentrations achieved with an every‑4‑week dosing regimen in pediatric patients 12 years of age and older who weigh at least 30 kg and have moderate-to-severe HS will be comparable to exposures observed in adults with moderate-to-severe HS.
Safety
According to the prescribing information for Cosentyx, the most common adverse reactions (>1%) are nasopharyngitis, diarrhea, and upper respiratory tract infection. The label also includes warnings regarding serious infections, hypersensitivity reactions, tuberculosis, inflammatory bowel disease, eczematous eruptions, and use of live vaccines.
Recommended dose
For pediatric patients 12 years and older with moderate-to-severe HS, the recommended weight-based dosage is as follows, administered subcutaneously at weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter:
- Weight ≥30 kg and <90 kg: 150 mg dose
- Weight ≥90 kg: 300 mg dose
Sources:
(2026, March 13). Novartis Cosentyx receives FDA approval for pediatric patients aged 12+ with moderate to severe hidradenitis suppurativa. [Press release]. https://www.novartis.com/news/media-releases/novartis-cosentyx-receives-fda-approval-pediatric-patients-aged-12-moderate-severe-hidradenitis-suppurativa
Cosentyx (secukinumab). [Package insert]. Novartis. https://www.novartis.com/us-en/sites/novartis_us/files/cosentyx.pdf Revised March 2026.