The US Food and Drug Administration has approved secukinumab (Cosentyx) for pediatric patients aged 12 years and older with moderate to severe hidradenitis suppurativa (HS), expanding biologic treatment options for adolescents with the chronic inflammatory skin disease, according to a press release from Novartis. Secukinumab is the only interleukin-17A inhibitor approved for pediatric patients with HS and introduces a differentiated IL-17A mechanism not seen in HS therapies in nearly a decade.

The approval adds a biologic treatment option for pediatric patients with moderate to severe HS, a population with limited treatment options. HS is a chronic, systemic inflammatory disorder characterized by recurrent, boil-like nodules that may rupture into painful wounds and lead to irreversible scarring. The disease frequently develops around puberty, and more than half of patients experience symptom onset during adolescence. Globally, HS may affect approximately 1 in 100 people, and diagnosis may be delayed for as long as 10 years.

The pediatric indication was supported by well-controlled adult HS studies, pharmacokinetic modeling extrapolated from adult HS and psoriasis trials, and pediatric clinical trial data from other approved indications. Dosing analyses predicted that weight-based dosing in pediatric patients weighing at least 30 kg would produce drug exposure comparable with that observed in adults with HS.

Secukinumab directly inhibits interleukin-17A, a cytokine involved in inflammation underlying multiple immune-mediated inflammatory diseases. The therapy is approved for adults with HS, psoriatic arthritis, moderate to severe plaque psoriasis, ankylosing spondylitis, and nonradiographic axial spondyloarthritis, as well as for pediatric patients with HS, plaque psoriasis, enthesitis-related arthritis, and juvenile psoriatic arthritis.

Source: Novartis