U.S. FDA Approves GATTEX (teduglutide) for Children 1 Year of Age and Older With Short Bowel Syndrome (SBS)

Takeda announced that FDA approved extending the GATTEX (teduglutide) indication to pediatric patients 1 year of age and older with short bowel syndrome who depend on parenteral support. The approval was supported by a 24-week pediatric study (NCT02682381) in 59 patients aged 1-17. In the study, 69% (18/26) of patients on GATTEX 0.05 mg/kg/day reduced parenteral-support volume by 20% or more, and 3 of 26 (12%) weaned off parenteral support entirely.