FDA approves expended indication for Stelara (ustekinumab) in moderate to severe plaque psoriasis.- Janssen Biotech.

Janssen Biotech announced that the FDA has approved an expanded indication for 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. This approval is significant 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.

The approval of Stelara for the adolescent indication in moderate to severe plaque psoriasis is based on data from a Phase III 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.