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Pediatric drug development programs for type 2 diabetes: A review
Author(s) -
Christensen Michael L.,
Franklin Brandi E.,
Momper Jeremiah D.,
Reed Michael D.
Publication year - 2015
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1002/jcph.497
Subject(s) - medicine , metformin , drug , food and drug administration , intensive care medicine , drug development , type 2 diabetes , adverse effect , type 2 diabetes mellitus , diabetes mellitus , drug approval , pharmacology , clinical pharmacology , clinical research , endocrinology
Considerable progress has been made in pediatric drug development. Despite these gains there remain certain therapeutic areas where a high percentage of drugs approved for use in adults do not gain approval for use in children. Lack of sufficient US Food and Drug Administration (FDA)–approved labeling correlates with diminished therapeutic efficacy and increased risk for adverse drug reactions. Despite the increasing prevalence and important clinical challenge with pediatric type 2 diabetes mellitus (T2DM), only 1 drug (metformin) of the first 4 T2DM drugs to complete testing in children gained FDA approval. This analysis reviews 4 pediatric drug development programs for orally administered antidiabetic agents that have undergone FDA review and discusses factors influencing failure to meet specified end points for approval. Recommendations to guide future study are also provided.