The Food and Drug Administration approval of ustekinumab has been expanded to include adolescents aged 12 and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, based on the results of a phase 3 study.
The manufacturer, Janssen Biotech, announced the expanded indication in a press release on Oct. 13.
Ustekinumab, an interleukin-12 and -23 antagonist administered subcutaneously, was first approved by the FDA in 2009 for the same indication in adults; it is also approved for adults with active psoriatic arthritis, and for adults with moderately to severely active Crohn’s disease.
Ustekinumab is marketed as Stelara.
