J&J Announces STELARA® FDA Approval for Pediatric Crohn’s Disease
The recent STELARA FDA approval provides a crucial new non-TNF biologic treatment option for children two years and older suffering from moderately to severely active Crohn’s disease.
The recent STELARA FDA approval provides a crucial new non-TNF biologic treatment option for children two years and older suffering from moderately to severely active Crohn’s disease.
Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the FDA for STELARA® (ustekinumab) to treat children aged two years and older with moderately to severely active ulcerative colitis. The filing is supported by data from the Phase 3 UNIFI Jr clinical trial, aiming to address the significant unmet needs for this pediatric patient population.