Novartis Cosentyx receives EU approval for first-line systemic treatment in pediatric psoriasis

• EU approval is based on two Phase III studies showing Cosentyx provides fast and strong skin clearance, along with significant improvement in quality of life and a favorable safety profile¹
   
• Moderate-to-severe psoriasis affects more than 350,000 children worldwide², with the physical and psychological burden disrupting important formative years³
   
• Cosentyx is a proven brand, supported by long-term five-year sustained efficacy and safety data across psoriasis, psoriatic arthritis (PsA) and ankylosing spondylitis (AS), over 100 studies and with more than 340,000 patients treated worldwide since launch^4,5,6,7
   
• Approval reinforces Cosentyx leadership in immuno-dermatology and rheumatology, following recent EU approval in non-radiographic axial spondyloarthritis (nr-axSpA), with plans to expand to 10 indications over the next 10 years

Basel, August 3, 2020 — Novartis, a leader in immuno-dermatology and rheumatology, today 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 weeks¹.

“The impact of psoriasis on children is much deeper than skin and can potentially lead to life course impairment,” said Todd Fox, Global Head of Medical Affairs Immunology, Hepatology and Dermatology at Novartis. “This is the second European approval this year for Cosentyx, which also has approvals across four adult indications, reinforcing our commitment to reimagine medicine for both pediatric and adult patients.”