New FDA Approval to Treat Moderate to Severe Pediatric Psoriasis

The FDA announced approval of secukinumab, an IL-17 inhibitor, for the treatment of moderate to severe plaque psoriasis in patients aged 6 years and older.

The approved dosing is 75 mg or 150 mg, dependent on the child’s weight at dosing (<50kg and ≥50kg, respectively), and is administered by subcutaneous injection every 4 weeks following an initial loading regimen. Trained adult caregivers can administer secukinumab either by single-dose prefilled syringe or by autoinjector pen.

Approval is based on two phase 3 studies that evaluated secukinumab in patients aged 6 to less than 18 years. In a 52-week, randomized, double-blind, placebo- and active-controlled study, secukinumab reduced psoriasis severity at week 12 compared with placebo. Of the 162 included patients, 70% of patients receiving either dosing of secukinumab achieved Psoriasis Area Severity Index (PASI) 75. Similarly, 56% of patients receiving secukinumab achieved clear or almost clear skin responses on Investigator’s Global Assessment. The second trial, a randomized open-label, 208-week trial of 84 patients aged 6 years and older, demonstrated similar efficacy and safety.

Secukinumab is also indicated to treat moderate to severe plaque psoriasis in patients aged 18 years and older, active psoriatic arthritis, active ankylosing spondylitis, and active nonradiographic axial spondylarthritis and objective signs of inflammation.

Reference
Novartis Cosentyx receives FDA approval for treatment of children and adolescents with moderate to severe plaque psoriasis. News release. Novartis Pharmaceuticals Corporation; June 1, 2021. Accessed June 1, 2021. https://prnmedia.prnewswire.com/news-releases/novartis-cosentyx-receives-fda-approval-for-treatment-of-children-and-adolescents-with-moderate-to-severe-plaque-psoriasis-301303365.html