New indication for Janssen's Stelara approved in USA

The US Food and Drug Administration has approved an expanded indication for Stelara (ustekinumab) as a treatment for pediatric patients (six-11 years of age) who struggle with the skin lesions or plaques associated with moderate to severe plaque psoriasis (PsO), marketed by US healthcare giant Johnson & Johnson’s (NYSE: JNJ) subsidiary Janssen Pharmaceutical.

The European Medicines Agency cleared use of Stelara, a drug that generated sales of $1.7 billion in the second quarter of this year, in pedatric patients with severe plaque psoriasis in January this year.

Plaque psoriasis is the most common form of psoriasis in adults and children. Stelara targets both interleukin (IL)-12 and IL-23, two cytokines thought to play an important role in modulating the overactive inflammatory response in a number of autoimmune conditions, including PsO.