A Regulatory Review Approach for Evaluation of Micafungin for Treatment of Neonatal Candidiasis
| Autor: | Gillian Taormina, Kellie S. Reynolds, Ramya Gopinath, Yuliya Yasinskaya, Sumati Nambiar, Philip Colangelo, Jason N. Moore |
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| Rok vydání: | 2021 |
| Předmět: |
Adult
0301 basic medicine Microbiology (medical) medicine.medical_specialty Antifungal Agents 030106 microbiology Antifungal drug Unmet needs 03 medical and health sciences 0302 clinical medicine Pharmacokinetics medicine Humans Candidiasis Invasive 030212 general & internal medicine Clinical efficacy Intensive care medicine Neonatal Candidiasis business.industry Incidence (epidemiology) Infant Newborn Micafungin Infant medicine.disease Infectious Diseases Systemic candidiasis business medicine.drug |
| Zdroj: | Clinical Infectious Diseases. 73:2335-2340 |
| ISSN: | 1537-6591 1058-4838 |
| DOI: | 10.1093/cid/ciab025 |
| Popis: | Pathogenesis of neonatal candidiasis (NC) is distinct from systemic candidiasis in adults and older pediatric patients due to the significant incidence of central nervous system involvement in neonates. Thus, although adequate and well-controlled trials in NC are often unfeasible due to difficulty enrolling patients, extrapolation of efficacy from antifungal drug trials in adults is generally not appropriate. However, treatment of NC is an area of great unmet need. We describe a regulatory review approach that combined the assessment of limited clinical efficacy, pharmacokinetics, and safety data from neonates and young infants along with microbiology outcomes and pharmacokinetic data from relevant nonclinical models of candidemia/invasive candidiasis to inform the use of micafungin in pediatric patients younger than 4 months, while communicating areas of remaining uncertainty in labeling. |
| Databáze: | OpenAIRE |
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