Janssen-Cilag International NV (Janssen) announced that a Type 2 Variation has been filed with the European Medicines Agency seeking approval of Stelara (ustekinumab) for the treatment of moderate to severe plaque psoriasis in pediatric patients ages 12 to 17 years old who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
There currently are limited options for this population in the European Union. In general, children living with moderate to severe psoriasis must contend with a potentially disfiguring and lifelong disease that can permanently impair psychological development.
“Janssen is committed to the continued development of Stelara, especially in this underserved pediatric population,” said Newman Yeilding, M.D., head of immunology development, Janssen Research & Development, LLC. “We look forward to collaborating with the European Medicines Agency in working towards providing a new treatment option for dermatologists and pediatric patients 12 years and older who may benefit from Stelara.”
The application is supported by data from the Phase 3 CADMUS registration study, which evaluated the efficacy and safety, as well as improvements in quality of life, among adolescents (pediatric patients ages 12 to 17) receiving Stelara compared with patients receiving placebo.
Date: October 10, 2014
Filed Under: Drug Discovery