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
Ref: Takeda | Image: Takeda
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