FDA Green-Lights Novartis’ Cosentyx for Pediatric Arthritis Indications

Novartis’ blockbuster Cosentyx (secukinumab) has nabbed new FDA approvals for treating active enthesitis-related arthritis (ERA) in patients four years old and up and active juvenile psoriatic arthritis (JPsA) in children at least two years old.

The agency’s decision was supported by an 86-person phase 3 study showing that patients with active JPsA given Cosentyx saw an 85 percent reduction in risk of arthritic flare vs. placebo, and that patients with active ERA given Cosentyx experienced a 53 percent reduction in risk of arthritic flare vs. placebo.

Novartis is also seeking approval of Cosentyx for treating ERA and JPsA in Europe and said it expects a regulatory decision “in the coming months.”

Cosentyx earned global revenue of almost $4 billion in 2020.