FDA Approves Stelara for Treatment of Adolescents with Moderate To Severe Plaque Psoriasis

The FDA approved an expanded indication for Janssen Biotech, Inc.'s Stelara (ustekinumab) for the treatment of adolescents (12 years of age or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Today's approval marks a significant milestone for this age group as approximately one-third of individuals who develop plaque psoriasis do so before 20 years of age, and there are limited treatment options for adolescents. Since receiving approval in September 2009 for the treatment of adults living with moderate to severe plaque psoriasis, Stelarahas become a leading therapeutic option for dermatologists and their patients, with only four doses a year after two starter doses. 

"Psoriasis can affect many aspects of everyday life and the visible plaques, itching and discomfort can take a particular toll on adolescents," said Andrew Greenspan, MD, Vice President of Medical Affairs at Janssen. "With today's approval, Stelara has the potential to make a meaningful difference in the lives of these young adults."

The approval of Stelarafor the adolescent indication in moderate to severe plaque psoriasis is based on data from a Phase 3 study designed to evaluate the efficacy and safety of subcutaneous administration of Stelara in patients aged 12 years or older. At least two-thirds of patients receiving Stelara were responders at the week 12 primary endpoint after just two doses at weeks 0 and 4, defined by achieving a Physician's Global Assessment (PGA) score of 0 or 1 (cleared or minimal psoriasis). Safety findings for adolescent patients treated with Stelara were consistent with those seen in studies in adults with plaque psoriasis.

"Psoriasis is a highly visible disease, and it is essential that these younger patients and their caregivers have options that can effectively reduce the difficult-to-conceal and often misunderstood plaques," said Michael Siegel, PhD, Senior Vice President of Research and Clinical Affairs for the National Psoriasis Foundation. "It is encouraging to have new treatment options where few exist for adolescents living with psoriasis during such formative times in their lives."²