Posted by Michael Wonder on 31 Jul 2020
U.S. Food and Drug Administration approves Stelara (ustekinumab) for treatment of paediatric patients with moderate to severe plaque psoriasis
30 July 2020 - Stelara is the first and only biologic to target interleukin (IL)-12 and IL-23 approved for paediatric psoriasis use, providing a new proven treatment for children (6-11 years of age) who have had few available options.
Janssen today announced that the U.S. FDA has approved an expanded indication for Stelara (ustekinumab) as a treatment for paediatric patients (6-11 years of age) who struggle with the skin lesions or plaques associated with moderate to severe plaque psoriasis.
The FDA approval of Stelara for paediatric use is based on results from the CADMUS Junior study, an open-label, single-arm, multi-centre phase 3 clinical trial, of 44 patients with moderate to severe plaque psoriasis in which 77% of patients achieved clear or almost clear skin, at week 12 after two doses.
