FDA Approves Secukinumab for Children, Adolescents with Moderate to Severe Plaque Psoriasis
This is the first approval for secukinumab in a pediatric population in the United States for severe plaque psoriasis.
Officials with the FDA have approved secukinumab (Cosentyx) for the treatment of children and adolescents with moderate to severe plaque psoriasis, according to a press release from Novartis.
Secukinumab is the first and only fully human biologic that directly inhibits interleukin-17A, which is involved in the inflammation and development of moderate to severe plaque psoriasis, according to the press release. It is also the only biologic with proven efficacy in all 6 key manifestations of psoriatic arthritis.
The approval is based on pivotal trial data that demonstrated superior improvements of skin symptoms in patients treated with secukinumab. Investigators also found a safety profile in pediatric patients consistent with the established adult psoriasis indication. According to the press release, this is the first approval for secukinumab in a pediatric population in the United States.
Psoriasis is a common chronic, inflammatory condition impacting approximately 8 million Americans and 1% of children and adolescents in the United States, according to the press release. Onset of the condition is most common during adolescence, with one-third of cases beginning in pediatric patients. The researchers noted that it can have a significant negative impact on children’s quality of life.
“The impact of psoriasis on children is much deeper than skin and can potentially lead to life course impairment,” said Angelika Jahreis, MD, PhD, global head of the Novartis development unit for Immunology, Hepatology, and Dermatology, in the press release. “With more than 400,000 patients treated in over 100 countries worldwide, we continue to build on the established safety and efficacy profile of Cosentyx, with plans to expand to 10 indications over the next 10 years.”
Two phase 3 studies evaluated secukinumab in children aged 6 years to less than 18 years with plaque psoriasis. The first study, which evaluated efficacy and safety, included 162 children with severe plaque psoriasis. It showed that treatment with secukinumab reduced psoriasis severity at week 12 compared with placebo, with 32% of secukinumab recipients showing clear or almost clear skin response compared to 5% of patients receiving the placebo.
The second study assessed safety in 84 subjects with moderate to severe plaque psoriasis. It found a safety profile consistent with secukinumab use in adults and no new safety signals were observed.
“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 clinical trial investigator John Browning, MD, FAAD, FAAP, MBA, in the press release. “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.”
Novartis Cosentyx receives FDA approval for treatment of children and adolescents with moderate to severe plaque psoriasis [news release]. Novartis; June 1, 2021. https://www.novartis.com/news/media-releases/novartis-cosentyx-receives-fda-approval-treatment-children-and-adolescents-moderate-severe-plaque-psoriasis. Accessed June 3, 2021.