European Commission approves Cosentyx for the treatment of moderate-to-severe plaque psoriasis in children and adolescents. -Novartis

Novartis, announced the European Commission (EC) has granted the approval for Cosentyx (secukinumab) for the treatment of moderate-to-severe plaque psoriasis in children and adolescents aged 6 to <18 years. the recommended dose for children up to 50 kg is 75 mg (without a lower weight restriction), and 150 mg for children 50 kg and over (150 mg as a starting dose, which may be increased to 300 mg, if needed). “psoriasis is a life-long debilitating disease that significantly impacts children’s quality of life, both physically and emotionally. 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.” 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 favorable safety profile up to 52 weeks.>