CHMP recommends approval of Stelara (ustekinumab) for plaque psoriasis in adolescents- Janssen-Cilag

The CHMP of the European Medicines Agency adopted a positive opinion recommending approval for the use of Stelara (ustekinumab), from Janssen-Cilag, for the treatment of moderate to severe plaque psoriasis in adolescent patients from the age of 12 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.

The CHMP adopted the opinion based on a review of data from the CADMUS study, which is a Phase III randomised, double-blind, placebo-controlled, multicentre trial designed to evaluate the safety and efficacy of Stelara in patients aged 12 to 17 years with moderate to severe plaque psoriasis. Based on the CHMP's positive opinion, a final decision from the European Commission is expected during the third quarter of 2015. If approved, Stelara will become available for the treatment of adolescents from the age of 12 years and older living with moderate to severe plaque psoriasis, a chronic autoimmune disease that affects from 0.5 to 2 per cent of the general population during childhood and adolescence.