EU Expands Approval of Novartis’ Cosentyx for Pediatric Arthritis

The EU has expanded approval of Novartis’ Cosentyx (secukinumab), alone or with methotrexate, to include patients six years and older with enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) who have not responded adequately to conventional therapy.

The expanded approval was based on positive results in a phase 3 study in which participants treated with Cosentyx responded significantly better than the placebo cohort.

The injectable drug is already approved in the EU for the treatment of patients over six years old who have moderate-to-severe plaque psoriasis and for adult patients who have psoriatic arthritis or axial spondyloarthritis.

Cosentyx, a human interleukin-17A antagonist, is also FDA-approved for active psoriatic arthritis and active ankylosing spondylitis in adults. In December 2021, the agency approved it for treatment of ERA in patients four years and older, and JPsA in patients two years and older.