BRIEF—Janssen seeks to add pediatric psoriasis patients to Stelara label

Healthcare giant Johnson & Johnson’s Janssen unit has submitted a supplemental Biologics License Application to the US Food and Drug Administration seeking to expand the label for Stelara (ustekinumab) to pediatric patients with moderate to severe plaque psoriasis.

Stelara is currently approved in many countries for the treatment of adolescents and adults with moderate to severe plaque psoriasis, as well as for adults with active psoriatic arthritis, moderate to severe Crohn's disease and moderate to severe ulcerative colitis in the European Union.

Janssen also submitted a marketing application this year to the European Medicines Agency seeking approval of Stelara as a treatment for pediatric patients with plaque psoriasis.