BRIEF—EC approves Stelara for younger patients

The European Commission has approved the expanded use of Stelara (ustekinumab) for the treatment of pediatric patients (ages 6–11) with moderate to severe plaque psoriasis, according to Janssen, the Rx medicines unit of US healthcare giant Johnson & Johnson.

Stelara, which generated sales of $6.36 billion for the company in 2019, was previously indicated in adolescent and adult patients with plaque psoriasis, aged 12 years and older and is now the first available biologic treatment in this pediatric patient population to selectively address the IL 23/IL 12 pathway.

There are 14 million cases of psoriasis in Europe where one-third begin in childhood. The EC approval is based on results from the Phase III CADMUS Jr study which found Stelara improved the signs and symptoms of plaque psoriasis, as well as health-related quality of life, in pediatric patients aged six to 11 years old after 12 weeks. Safety data were consistent with the known safety profiles of Stelara.