Racial/ethnic differences in drug disposition and response: Review of recently approved drugs
A Ramamoorthy
Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA
Search for more papers by this authorMA Pacanowski
Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA
Search for more papers by this authorJ Bull
Office of Minority Health, Office of the Commissioner, US Food and Drug Administration, Silver Spring, Maryland, USA
Search for more papers by this authorCorresponding Author
L Zhang
Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA
Correspondence: L Zhang ([email protected]).Search for more papers by this authorA Ramamoorthy
Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA
Search for more papers by this authorMA Pacanowski
Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA
Search for more papers by this authorJ Bull
Office of Minority Health, Office of the Commissioner, US Food and Drug Administration, Silver Spring, Maryland, USA
Search for more papers by this authorCorresponding Author
L Zhang
Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA
Correspondence: L Zhang ([email protected]).Search for more papers by this authorAbstract
Race and ethnicity can contribute to interindividual differences in drug exposure and/or response, which may alter risk–benefit in certain populations. Approximately one-fifth of new drugs approved in the past 6 years demonstrated differences in exposure and/or response across racial/ethnic groups, translating to population-specific prescribing recommendations in a few cases. When data from diverse populations were lacking, additional postmarketing studies were recommended. In this review we highlight several cases where race/ethnicity was central to regulatory decision-making.
Supporting Information
Additional supporting information may be found in the online version of this article.
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Supplementary Material Figure 1 Therapeutic area distribution (%) of NMEs approved (n = 167) and those that reported interracial/ethnic differences (n = 35) in the labeling. Note: The percentages for therapeutic area distribution are based on 167 NMEs approved in the study period (2008–2013). The percentages for interracial/ethnic differences are based on 35 NMEs that report differences based on PK, safety, efficacy and/or pharmacogenetics in the labeling. |
| cpt61-sup-0002-suppfig2.jpg728.3 KB |
Supplementary Material Figure 2: Availability of race/ethnicity information and interracial/ethnic differences reported in the NME labeling. Note: Δ: The effect of race/ethnicity was not discussed for PK (n = 76), safety (n = 151), and efficacy (n = 135) in the labeling, however this information may be available in FDA reviews; *: >20% change in AUC and/or Cmax; #: Dose adjustments in CYP2D6 or CYP2C19 poor metabolizers and contraindication in G6PD deficiency. |
| cpt61-sup-0003-supptable1.doc55 KB |
Supplementary Material Table 1. |
| cpt61-sup-0004-supptable2.doc43.5 KB |
Supplementary Material Table 2. |
| cpt61-sup-0005-suppinfo5.xml3.1 KB |
Supplementary Material |
Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.
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