FDA Approves Stelara for Pediatric Ulcerative Colitis; Vedolizumab Shows Remission in KEPLER Trial
The FDA approved Stelara for pediatric ulcerative colitis in patients aged 2 years and older. Takeda's Phase 3 KEPLER trial showed intravenous vedolizumab achieved clinical remission in 47.3% of pediatric patients at Week 54, with a safety profile consistent with adults.