Posted by Michael Wonder on 28 Jun 2020
Novartis Cosentyx gains positive CHMP opinion for paediatric psoriasis, reinforcing established efficacy and safety profile
26 June 2020 - EMA CHMP positive opinion paves way for Cosentyx to become a first-line systemic treatment in paediatric psoriasis.
Novartis, a leader in immuno-dermatology and rheumatology, today announced the Committee for Medicinal Products for Human Use of the European Medicines Agency 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.
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.
