Janssen files for EU approval of Stelara in pediatric plaque psoriasis

US health care giant Johnson & Johnson’s (NYSE: JNJ) Belgium-based subsidiary Janssen-Cilag International says that a Type II 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 aged 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. Stelara, a biologic approved for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis, generated sales of $528 million in the second quarter of 2014, a year-on-year rise of 41.3%.

"Janssen is committed to the continued development of Stelara, especially in this underserved pediatric population," said Newman Yeilding, head of immunology development at Janssen Research & Development, adding: "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."