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A 12-Week Pharmacokinetic, Safety, and Pharmacodynamic Study of Teduglutide in Paediatric Subjects Aged 1 Year Through 17 Years, With Short Bowel Syndrome Who Are Dependent on Parenteral Support

Trial Profile

A 12-Week Pharmacokinetic, Safety, and Pharmacodynamic Study of Teduglutide in Paediatric Subjects Aged 1 Year Through 17 Years, With Short Bowel Syndrome Who Are Dependent on Parenteral Support

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 May 2019

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At a glance

  • Drugs Teduglutide (Primary)
  • Indications Short bowel syndrome
  • Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics
  • Sponsors NPS Pharmaceuticals
  • Most Recent Events

    • 17 May 2019 According to a Takeda media release, the U.S. Food and Drug Administration (FDA) approved extending the indication of GATTEX (teduglutide) for injection to pediatric patients 1 year of age and older with Short Bowel Syndrome (SBS) who need additional nutrition or fluids from intravenous (IV) feeding (parenteral support).
    • 13 Nov 2018 According to a Shire media release, the U.S. Food and Drug Administration (FDA) has accepted for filing the supplemental new drug application to extend the indication of GATTEX (teduglutide [rDNA origin]) for injection to paediatric patients (aged 1-17 years old) with Short Bowel Syndrome (SBS) who are dependent on parenteral support. The company submitted the sNDA on September 11, 2018 and the FDA decision is expected in March 2019.
    • 15 Nov 2016 Results published in the Journal of Pediatrics.
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