European Commission approves use of Stelara in paediatric patients with plaque psoriasis. Johnson & Johnson

Johnson & Johnson announced that the European Commission (EC) has approved the label expansion of Stelara (ustekinumab) for the treatment of moderate-to-severe plaque psoriasis in paediatric patients aged between six and 11 years for whom there are limited biologic treatment options. In December 2019, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) rendered a positive opinion recommending the marketing approval of Stelara to treat the above-mentioned patient population. With the latest approval in the EU, Stelara becomes the first available biologic treatment to deal with the given patient population to selectively address the IL-23/IL-12 pathway, an important therapeutic target for the given condition. The EC’s approval for plaque psoriasis in pediatric patients was based on data from the phase III CADMUS Jr study. Results from the same showed that treatment with Stelara led to improved signs and symptoms of plaque psoriasis as well as better health-related quality of life in children aged from six to 11 years, who are living with this chronic disease. Stelara is also under the FDA review for plaque psoriasis in pediatric patients.