Novartis has gained European approval for Cosentyx (secukinumab) for the treatment of moderate-to-severe plaque psoriasis in children and adolescents aged 6 to <18 years. The approval is based on two Phase III international studies in children and adolescents aged 6 to <18 years. The studies showed that 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 favourable safety profile up to 52 weeks. “There are only a few approved treatment options available for the pediatric population and so it is important to broaden the adult therapeutic options out to children when possible,” said Professor Christine Bodemer, Head of the Department of Dermatology, Necker–Enfants Malades Hospital, Paris. “This approval means Cosentyx is now available in Europe for children and adolescents, and will provide an additional option to quickly gain relief from their symptom burden and to significantly improve their quality of life.” Novartis said it is working closely with all stakeholders to ensure that eligible European paediatric patients can start benefitting from Cosentyx as quickly as possible.
Novartis will also be seeking approval for Cosentyx for the treatment of moderate-to-severe plaque psoriasis in children and adolescents aged 6 to <18 years in a number of other countries including Australia, Canada, Japan and the US.