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

(RTTNews) - 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.