FDA Approves Novartis Cosentyx for Children with Plaque Psoriasis

Novartis, a leader in immuno-dermatology and rheumatology, announced that the FDA has approved Cosentyx® (secukinumab) for the treatment of moderate to severe plaque psoriasis in pediatric patients six years and older who are candidates for systemic therapy or phototherapy. This is the first approval for Cosentyx in a pediatric population in the US. The Cosentyx clinical profile is supported by five years of adult data showing long-lasting efficacy and a consistent safety profile across moderate to severe plaque psoriasis, psoriatic arthritis and ankylosing spondylitis.

“Treating moderate to severe plaque psoriasis in children can be complicated, as we need to balance the ability of a treatment to provide symptom relief while considering the safety profile as the top priority,” said John Browning, MD, FAAD, FAAP, MBA, clinical trial investigator, Adjunct Associate Professor of Pediatrics and Dermatology at the University of Texas Health, San Antonio. “In the pediatric pivotal study, the majority of patients treated with Cosentyx were able to achieve clear or almost clear skin with a safety profile consistent with previous clinical trials in adults. Due to the systemic nature of the disease, Cosentyx is a welcome addition as a treatment option for families dealing with this challenging condition.”

Psoriasis is a common chronic, inflammatory condition that affects approximately 8 million Americans and 1% of children and adolescents in the US. Onset is most common during adolescence, with one-third of psoriasis cases beginning in the pediatric years. Psoriasis can have a negative impact on the quality of life of children, especially during their formative years.