The U.S. Food and Drug Administration (FDA) has approved Novartis’ blockbuster drug Cosentyx® (secukinumab) for pediatric patients aged six years and older with moderate-to-severe plaque psoriasis. The new approval for Cosentyx marks the first for a pediatric patient population in the U.S.
In the U.S., psoriasis affects approximately 1% of children and adolescents. Approximately one-third of cases begin during childhood and adolescence, a time in which the disease can have a significant impact on quality of life.
Cosentyx is the only fully human biologic agent that inhibits interleukin-17A (IL-17A) directly. The IL-17A is considered a “cornerstone cytokine” implicated in inflammation as well as the development of psoriasis and psoriatic arthritis. Cosentyx has up to 5 years’ worth of clinical efficacy and safety data in adults with moderate-to-severe plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis.
Clinical Basis of Approval
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 observed.
The first study, which evaluated efficacy and safety, was a 52-week (236 weeks total), randomized, double-blind, placebo- and 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 ≥50kg): Psoriasis Area Severity Index (PASI) 75 response (55% 75 mg vs 10% placebo (N=22 and N=20, respectively), 86% 150 mg vs 19% placebo (N=21 and N=21, respectively), 70% total Cosentyx vs 15% total placebo (N=43 and N=41, respectively) and Investigator’s Global Assessment modified 2011 (IGA) “clear” or “almost clear” skin response (32% 75 mg vs 5% placebo, 81% 150 mg vs 5% placebo, 56% total Cosentyx vs 5% total placebo), co-primary endpoints of the study.
The second Phase III study, which assessed safety, was a randomized open-label, 208-week trial of 84 subjects six years of age and older with moderate to severe plaque psoriasis.