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CompilationFan Dongdong
The U.
This FDA approval marks the first time the biologic Cosentyx has been approved for ERA
The latest approval of Cosentyx is based on the Phase III study of JUNIPERA, a 2-year, three-part, double-blind, placebo-controlled, randomized withdrawal Phase 3 study that enrolled 86 patients aged 2 to 17 years, Children and adolescents with a diagnosis of JPsA or ERA according to the International Federation of Rheumatology Association classification criteria
The study showed that in pediatric patients treated with Cosentyx for both indications, an 85% lower risk of relapse was found in adolescent patients with PsA and a 53% lower risk in adolescent patients with ERA
Currently, treatment options to help improve joint inflammation, dactylitis, and enthesitis are very limited for this population
Cosentyx is an inhibitor of interleukin-17A (IL-17A), which is produced by various cells from the innate immune system (which can be triggered by mechanical stress) and the adaptive immune system
The FDA approval of Cosentyx further strengthens Novartis' commitment to the pediatric community, Victor Bulto, head of Novartis' U.
In addition to the U.
Reference source: Novartis Drug Approved for Juvenile ERA and Psoriatic Arthritis
