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Pediatric drug development programs for type 2 diabetes: A review.

Michael L Christensen1, Brandi E Franklin1, Jeremiah D Momper2

  • 1Department of Clinical Pharmacy and the Center for Pediatric Pharmacokinetics and Therapeutics, University of Tennessee Health Science Center, Memphis,, TN, USA.

Journal of Clinical Pharmacology
|March 18, 2015
PubMed
Summary

Pediatric drug development for type 2 diabetes mellitus (T2DM) faces challenges, with only one of four oral antidiabetic agents gaining US Food and Drug Administration (FDA) approval for children. This review examines factors hindering approval for pediatric T2DM treatments.

Keywords:
adolescentsclinical trial designtype 2 diabetes mellitus

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Area of Science:

  • Pediatric pharmacology and regulatory science.
  • Endocrinology and metabolic diseases.

Background:

  • Pediatric drug development has advanced, yet significant gaps exist, particularly in therapeutic areas where adult-approved drugs lack pediatric labeling.
  • Lack of FDA-approved labeling in children is linked to reduced effectiveness and increased adverse drug reactions.
  • Pediatric type 2 diabetes mellitus (T2DM) is a growing concern, but approved treatment options remain limited.

Purpose of the Study:

  • To analyze pediatric drug development programs for orally administered antidiabetic agents.
  • To identify factors contributing to the failure of these drugs to meet US Food and Drug Administration (FDA) approval endpoints for pediatric use.
  • To provide recommendations for future pediatric drug development studies.

Main Methods:

  • Review of four pediatric drug development programs for oral antidiabetic agents.
  • Analysis of US Food and Drug Administration (FDA) review processes and outcomes.
  • Evaluation of factors influencing the achievement of specified endpoints for approval.

Main Results:

  • Only one of the first four oral antidiabetic agents tested in children received FDA approval for pediatric T2DM.
  • Specific factors contributing to the failure to meet approval endpoints were identified across the reviewed programs.
  • The analysis highlights a critical unmet need for effective and approved treatments for pediatric T2DM.

Conclusions:

  • Significant hurdles impede the FDA approval of oral antidiabetic agents for pediatric type 2 diabetes mellitus.
  • Understanding the factors influencing trial outcomes is crucial for improving future pediatric drug development.
  • Further research and strategic planning are necessary to expand the therapeutic options for children with T2DM.