FDA approval summary: Dalteparin for the treatment of symptomatic venous thromboembolism in pediatric patients

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Margret Merino1, Nicholas Richardson1, Gregory Reaman2

  • 1Office of Oncologic Diseases and Office of Clinical Pharmacology, U.S. Food and Drug Administration, Silver Spring, Maryland.

Pediatric Blood & Cancer
|September 8, 2020
PubMed

Insights

Dalteparin sodium is now FDA-approved for treating symptomatic venous thromboembolism (VTE) in pediatric patients one month and older, reducing recurrence risk. This approval supports its efficacy and safety in this young population.

Area of Science:

  • Pharmacology and Therapeutics
  • Pediatric Medicine
  • Hematology

Background:

  • Venous thromboembolism (VTE) poses a significant risk for pediatric patients.
  • Existing treatment options for pediatric VTE require careful consideration of efficacy and safety profiles.
  • The need for approved anticoagulant therapies in children is critical for managing VTE.

Purpose of the Study:

  • To evaluate the efficacy and safety of dalteparin sodium for treating symptomatic VTE in pediatric patients.
  • To assess the drug's ability to reduce the risk of VTE recurrence in children aged one month and older.
  • To support regulatory approval for dalteparin sodium in a pediatric VTE treatment context.

Main Methods:

  • A single-arm clinical trial was conducted involving 38 pediatric patients with symptomatic VTE.
  • Dalteparin sodium was administered subcutaneously twice daily.
  • Efficacy was determined by achieving therapeutic plasma anti-factor Xa (anti-Xa) levels.

Main Results:

  • The U.S. Food and Drug Administration (FDA) approved dalteparin sodium on May 16, 2019.
  • The approval was based on a trial demonstrating therapeutic plasma anti-Xa levels in pediatric patients.
  • The study indicated acceptable safety and efficacy of dalteparin sodium for the pediatric population.

Conclusions:

  • Dalteparin sodium is an effective treatment for symptomatic VTE in pediatric patients aged one month and older.
  • The drug demonstrates an acceptable safety profile for use in this young demographic.
  • FDA approval signifies the drug's role in reducing VTE recurrence risk in children.

Keywords:
low molecular weight heparinpediatric anticoagulationvenous thromboembolism

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