- Salix Pharmaceuticals introduces Rx topical foam to treat a form of inflammatory bowel disease
- FDA pushes back target date for review of Takeda drug in patients with ulcerative colitis
- Takeda starts phase-3 trials of vedolizumab
- FDA advisory committee recommends approval for Takeda's vedolizumab
- USPLabs agrees to recall and destroy dietary supplement following FDA actions
HORSHAM, Pa. — The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating ulcerative colitis in children.
J&J subsidiary Janssen Biotech said Friday that the FDA approved Remicade (infliximab) for moderately to severely active ulcerative colitis in children who have not responded adequately to conventional therapies.
"Ulcerative colitis can be a devastating disease, and previously there had been no approved therapeutic options for pediatric patients who had an inadequate response to conventional therapy," said Jeffrey Hyams, University of Connecticut medical professor and lead investigator of the clinical study that lead to the new approval. "The approval of infliximab represents an important treatment milestone in the care of children stricken with this inflammatory bowel disease."
According to the Crohn's and Colitis Foundation of America and the Starlight Children's Foundation, about 1.4 million Americans have irritable bowel syndrome, which includes ulcerative colitis and Crohn's disease, including 150,000 children younger than 17 years old.