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

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