Johnson & Johnson Submits sBLA to Expand Stelara Use for Pediatric Crohn’s Disease

Johnson & Johnson Submits sBLA to Expand Stelara Use for Pediatric Crohn's Disease

US giant Johnson & Johnson (J&J, NYSE: JNJ) this week submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) seeking to expand the indication of Stelara (ustekinumab) for the treatment of children aged 2 years and older with moderate to severe active Crohn’s disease (CD).

Current Approvals
Stelara is currently approved for adult patients with moderate to severe active Crohn’s disease and ulcerative colitis. It is also approved for the treatment of active ankylosing spondylitis, as well as moderate to severe plaque psoriasis in adults and pediatric patients aged 6 years and older.

Significance of the Application
The submission marks a significant step in making this treatment available to a younger patient population and reflects J&J’s commitment to expanding therapeutic options for children suffering from Crohn’s disease.-Fineline Info & Tech