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Novartis : Cosentyx Gets Positive CHMP Opinion For Expanded Use In Childhood Arthritic Conditions

Novartis (NVS) said Friday that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency or EMA has adopted a positive opinion for Cosentyx (secukinumab), used alone or in combination with methotrexate, in the juvenile idiopathic arthritis categories of enthesitis-related arthritis and juvenile psoriatic arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.

The positive CHMP opinion was based on data from the Phase III JUNIPERA study, a 2-year, three-part, double-blind, placebo-controlled, randomized withdrawal trial showing significantly longer time to flare in Cosentyx vs placebo in pediatric enthesitis-related arthritis and juvenile psoriatic arthritis patients. Safety in this pediatric population was consistent with the known safety profile of Cosentyx across approved adult and pediatric indications.

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