- Approval for moderate to severe pediatric patients six years and older is based on pivotal trial data showing Cosentyx demonstrated superior improvements of skin symptoms compared to placebo1
- The safety profile of Cosentyx in pediatric patients with plaque psoriasis was demonstrated in two Phase III trials and is consistent with the established adult psoriasis indication1
- Plaque psoriasis is a chronic, inflammatory disease that may impact up to 350,000 children worldwide, with onset most common during adolescence2,3
Basel, June 1, 2021 - Novartis, a leader in immuno-dermatology and rheumatology, today announced the U.S. Food and Drug Administration (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 phototherapy1. 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 spondylitis4-10.
"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 which affects approximately 8 million Americans and 1% of children and adolescents in the US2,11. Onset is most common during adolescence, with one-third of psoriasis cases beginning in the pediatric years2,12. Psoriasis can have a negative impact on the quality of life of children, especially during their formative years13.
The approved pediatric dosing for Cosentyx is 75 mg or 150 mg depending on the child’s weight at the time of dosing and is administered by subcutaneous injection every four weeks after an initial loading regimen1. After initial counseling and proper training in injection technique, Cosentyx can be administered by an adult caregiver outside of a healthcare provider’s office via a single-dose prefilled syringe or Sensoready pen.
"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 pediatric plaque psoriasis patients," said Angelika Jahreis MD, PhD, Novartis Global Head Development Unit Immunology, Hepatology & Dermatology. "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."
This Cosentyx approval is based on two Phase III studies evaluating the use of Cosentyx in children aged 6 to <18 years with plaque psoriasis. The safety profile reported in these trials was consistent with the safety profile reported in adult plaque psoriasis trials. No new safety signals were observed1.
The first study, which evaluated efficacy and safety, was a 52-week (236 weeks total), randomized, double-blind, placeboand active-controlled study which included 162 children six years of age and older with severe plaque psoriasis. The data showed Cosentyx reduced psoriasis severity at Week 12 compared with placebo as demonstrated by the following efficacy results by baseline weight strata for the approved doses (75mg for <50kg and 150mg for