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Janssen submits application for Stelara approval in EU for pediatric psoriasis

Janssen-Cilag International NV announced it has filed a Type II Variation with the European Medicines Agency for the approval of Stelara to treat moderate to severe plaque psoriasis in pediatric patients who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.

Current options in the EU for pediatric patients with psoriasis are limited, according to a company press release.

The application is supported by data from the phase 3, randomized, double-blind, placebo-controlled, parallel, multicenter CADMUS study, which evaluated the safety, efficacy and improvements in quality of life among 110 adolescents who received ustekinumab (Stelara) for the treatment of moderate to severe plaque psoriasis compared with those who received placebo.

Ustekinumab, a human interleukin (IL)-12 and IL-23 antagonist, is currently approved in 79 countries for the treatment of moderate to severe plaque psoriasis.

The drug is also approved in the EU for use in adults with moderate to severe plaque psoriasis who have not responded to, had a contraindication to or were intolerant to other systemic therapies, according to the release.