FDA Approves Johnson & Johnson's Simponi for Pediatric Ulcerative Colitis
AI-Generated Summary
The FDA has approved Johnson & Johnson's Simponi (golimumab) for children weighing at least 15 kg with moderately to severely active ulcerative colitis. This approval is supported by positive Phase 3 PURSUIT 2 study data, which demonstrated significant clinical remission and response rates. This marks Simponi's first pediatric indication, expanding its therapeutic reach.
In a nutshell
This expanded FDA approval provides a crucial new treatment option for pediatric patients suffering from ulcerative colitis and underscores Johnson & Johnson's continued investment in lifecycle management for established therapeutics.
Source: Benzinga
