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Novartis Says Cosentyx Gets Positive CHMP Opinion For Pediatric Psoriasis

Swiss drug major Novartis AG (NVS) said Friday that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency (EMA) has adopted a positive opinion for Cosentyx, or secukinumab, for the treatment of moderate-to-severe plaque psoriasis in children and adolescents aged 6 to less than 18 years.

"Psoriasis affects children much deeper than just the skin and can lead to deterioration of quality of life, potentially having a lasting impact on this vulnerable patient population. This is our second positive CHMP opinion for Cosentyx this year alone, following on from recent EC approval in nr-axSpA," said Todd Fox, Global Head of Medical Affairs Immunology, Hepatology and Dermatology at Novartis.

The positive CHMP opinion is based on two Phase III international studies in children and adolescents aged 6 to less than 18 years, one open-label, two-arm, parallel-group, multi-centre study with moderate-to-severe plaque psoriasis and one randomized, double-blind, placebo and etanercept-controlled study with severe plaque psoriasis.

The studies showed both low-dose (75-150 mg) and high-dose (75-300 mg) of Cosentyx were highly efficacious in rapidly improving skin symptoms and quality of life, with a favorable safety profile up to 52 weeks.

Psoriasis is a life-long debilitating systemic inflammatory disease that significantly impacts patients' quality of life, both physically and emotionally. One-third of psoriasis cases begin in childhood and of these the onset is most common during adolescence. Moderate-to-severe psoriasis affects more than 350,000 children worldwide.

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