Novartis Receives FDA Approval for Cosentyx in Pediatric Patients with Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis

Compiled by Fan Dongdong

Recently, the U.S. Food and Drug Administration (FDA) approved Novartis' Cosentyx for the treatment of active enthesitis-related arthritis (ERA) in patients aged four years and older, as well as for the treatment of active psoriatic arthritis (PsA) in patients aged two years and older.

This approval by the U.S. FDA marks the first time that the biologic Cosentyx has been approved for use in ERA. Cosentyx is also the only biologic approved in the U.S. for both ERA and PsA in pediatric patients. Overall, Cosentyx has now received five approvals from the FDA in rheumatology and dermatology.

The latest approval of Cosentyx is based on the Phase III JUNIPERA study, a two-year, three-part, double-blind, placebo-controlled, randomized withdrawal Phase III clinical trial that enrolled 86 pediatric and adolescent patients aged 2 to 17 years, diagnosed with JPsA or ERA according to the International League of Associations for Rheumatology classification criteria.

The study showed that in pediatric patients treated with Cosentyx for two indications, the risk of recurrence was reduced by 85% in adolescent PsA patients and by 53% in adolescent ERA patients. The safety profile of Cosentyx in pediatric patients was consistent with Novartis' known data. The findings confirm the significant efficacy of Cosentyx in treating ERA and JPsA pediatric patients.

Currently, for this population, treatment options that can help improve joint inflammation, dactylitis, and enthesitis are very limited. Both ERA (Enthesitis-Related Arthritis) and juvenile PsA (Psoriatic Arthritis) are subtypes of Juvenile Idiopathic Arthritis (JIA), which are autoimmune diseases. ERA is characterized by joint swelling, leading to pain where tendons and ligaments attach to bones. The disease features of juvenile PsA also include joint swelling and skin psoriasis. If left untreated, the condition can cause severe pain and disability in patients.

Cosentyx is an interleukin-17A (IL-17A) inhibitor, IL-17A is produced by various cells from the innate immune system (which can be triggered by mechanical stress) and the adaptive immune system. Cosentyx has previously been approved for the treatment of plaque psoriasis, active psoriatic arthritis, and ankylosing spondylitis.

Novartis Pharmaceuticals U.S. Head Victor Bulto said in a statement that the FDA approval of Cosentyx further strengthens Novartis' commitment to the pediatric population. Bulto noted that Cosentyx is a proven medication with a history of efficacy and safety across multiple systemic inflammatory conditions, and has been used by more than 500,000 patients globally since its launch.

Outside the U.S. market, Novartis is also actively seeking regulatory approval for Cosentyx for this indication in Europe. The Swiss pharmaceutical giant has already submitted a regulatory application for Cosentyx in ERA and JPsA in Europe. Novartis stated that it expects European regulatory authorities to make a decision in the coming months.

Reference Source: Novartis Drug Approved for Juvenile ERA and Psoriatic Arthritis