Novartis, announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Cosentyx (secukinumab) for the treatment of moderate-to-severe plaque psoriasis in children and adolescents aged 6 to <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,” said Todd Fox, Global Head of Medical Affairs Immunology, Hepatology and Dermatology at Novartis. “This is our second positive CHMP opinion for Cosentyx this year alone, following on from recent EC approval in nr-axSpA. The latest positive opinion is an important step forward in our commitment to reimagining care for children with psoriasis, giving them freedom to enjoy full and active lives.
The positive CHMP opinion is based on two Phase III international studies in children and adolescents aged 6 to <18 years, one open label, two-arm, parallel group, multicentre 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.