The US Food and Drug Administration (FDA) has approved Novartis’ interleukin-17A (IL-17A) inhibitor Cosentyx for the treatment of children and adolescents with moderate to severe plaque psoriasis.
Specifically, Cosenytx (secukinumab) has been cleared in the US to treat the inflammatory disease in paediatric patients aged six years and older who are candidates for systemic therapy or phototherapy – marking the first approval for the drug in a paediatric population.
This approval is based on two Phase III studies evaluating Cosenytx for the treatment of children aged six to <18 years with plaque psoriasis.
The first study evaluated the efficacy and safety of the IL-17A inhibitor over 52 week period and included 162 children aged six years and older with severe plaque psoriasis.
In this study, Cosentyx reduced psoriasis severity at week 12 compared with placebo, as measured by the Psoriasis Area Severity Index (PASI) 75 response and Investigator’s Global Assessment modified 2011 (IGA) “clear” or “almost clear” skin response.
The second study assessed the safety of Cosenytx across 208 weeks among 84 subjects aged six years and older with moderate to severe plaque psoriasis.
“The impact of psoriasis on children is much deeper than skin and can potentially lead to life course impairment. Today’s FDA approval further demonstrates our commitment to reimagine medicine for paediatric plaque psoriasis patients,” said Angelika Jahreis, global head development unit immunology, hepatology & dermatology, Novartis.
“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 ten years,” she added.
Approximately one-third of psoriasis cases begin in childhood, with the most common onset during adolescence. The condition could affect up to 350,000 children worldwide, and approximately 1% of children and adolescents in the US.
“Living with psoriasis is challenging, and can be highly stressful for children and adolescents,” said Randy Beranek, president and chief executive, National Psoriasis Foundation.
“Having expanded treatment options for this patient population is a step in the right direction to help reduce the burden of plaque psoriasis,” he added.
