The U.S. Food and Drug Administration (FDA) has approved the use of Cosentyx (secukinumab) for moderate-to-severe plaque psoriasis in pediatric patients aged six years and above.
This approval marks the first for a pediatric patient population in the U.S.
Novartis, a Swiss multinational pharmaceutical company, develops and markets the drug for the treatment of psoriasis, ankylosing spondylitis, and psoriatic arthritis.
Psoriasis affects approximately 1% of American children and adolescents. At least one-third of cases begin during childhood and adolescence, when the disease can have a significant impact on quality of life, according to BioSpace.
Dr. John Browning, a clinical trial investigator for Cosentyx, said the treatment of moderate-to-severe plaque psoriasis in children is complicated by the need “to balance the ability of a treatment to provide symptom relief while considering the safety profile as the top priority.”
Dr. Browning is also a pediatric dermatologist at the University of Texas Health in San Antonio.
Cosentyx is a human IgG1κ monoclonal antibody that binds to the protein interleukin-17A (IL-17A). IL-17A is a “cornerstone cytokine” implicated in inflammation and the development of psoriasis and psoriatic arthritis.
In adults with plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis, the drug has been found safe and effective.
The new approval of Cosentyx for children with psoriasis is based on two Phase 3 clinical trials that evaluated the therapy in children aged between 6 and 18. The evaluation found that the drug significantly reduced the severity of plaque psoriasis by week 12 compared with placebo.
Dr. Browning said, “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.”
A day after the FDA’s approval for Cosentyx in children, Novartis published positive results of Phase III data of the drug in juvenile idiopathic arthritis (JIA).
The findings were obtained from the JUNIPERA study, which showed treatment with Cosentyx led to a significantly delayed time to flare compared with placebo in children with two different subtypes of JIA, according to BioSpace.
Globally, JIA affects up to 2 million children but the disease has limited treatment options. In children, JIA is considered a debilitating and progressive disease that causes pain and functional disability.
Lead investigator Dr. Hermine Burnner of the Cincinnati Children’s Hospital Medical Center said, “The JUNIPERA data are encouraging and pave the way for an effective treatment option that delays the worsening of symptoms leading to improvement in quality of life for these children.” The article was published online on BioSpace.