Posted by Michael Wonder on 18 Jun 2025
Johnson & Johnson seeks US FDA approval of Stelara (ustekinumab) for the treatment of paediatric Crohn’s disease
17 June 2025 - Supported by 52 week data from the Phase 3 UNITI-Jr study, submission aims to expand Stelara indication to treat children two years of age and older.
Johnson & Johnson today announced the submission of a supplemental biologics license application to the US FDA seeking to expand approval of Stelara (ustekinumab) for the treatment of children two years and older with moderately to severely active Crohn’s disease.
