Takeda’s Gattex (teduglutide) Receives the US FDA’s Approval for Short Bowel Syndrome in Children

Takeda’s Gattex (teduglutide) Receives the US FDA’s Approval for Short Bowel Syndrome in Children

Shots:

  • The approval follows 24 wks. a pediatric study assessing Gattex (teduglutide, 0.025/0.05 mg/kg/day) vs SOC in 68 patients with SBS aged ≥ 1 yrs. who are dependent on parenteral support (PS)
  • The study resulted in 69% reduction in PS vol. by 20%+, 42% mean reduction in PS volume, 38% reduction in PS infusion by at least 1day/wk., reduction in PS infusion time by 3hrs., 12% completely weaned off PS
  • Gattex (teduglutide, IV) is an approved GLP-2 analog, helping the intestine to absorb nutrients and reducing the dependency on PS and is indicated both in adults & pediatric patients for SBS

Click here to read full press release/ article | Ref: Takeda | Image: News Hour