US FDA's Assessment of the Benefit-risk of Cefiderocol for its Initial Complicated Urinary Tract Infection Indication
- PMID: 34398951
- PMCID: PMC8366820
- DOI: 10.1093/cid/ciab010
US FDA's Assessment of the Benefit-risk of Cefiderocol for its Initial Complicated Urinary Tract Infection Indication
Comment on
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US Food and Drug Administration (FDA): Benefit-Risk Considerations for Cefiderocol (Fetroja®).Clin Infect Dis. 2021 Jun 15;72(12):e1103-e1111. doi: 10.1093/cid/ciaa1799. Clin Infect Dis. 2021. PMID: 33393598 Clinical Trial.
References
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- Naseer S, Weinstein EA, Rubin DB, et al. U.S. Food and Drug Administration (FDA): benefit-risk considerations for cefiderocol (Fetroja). Clin Infect Dis 2021; 72:e11003–11. - PubMed
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- Fetroja® Prescribing Information: Drugs@FDA, Reference ID: 4676517. revised 20 September 2020.
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- FDA identified breakpoints, cefiderocol injection. Available at: https://www.fda.gov/drugs/development-resources/cefiderocol-injection. Accessed 16 Jan 2021.
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- Bassetti M, Echols R, Matsunaga Y, et al. Efficacy and safety of cefiderocol or best available therapy for the treatment of serious infections caused by carbapenem-resistant Gram-negative bacteria (CREDIBLE-CR): a randomised, open-label, multicentre, pathogen-focused, descriptive, phase 3 trial. L ancet Infect Dis 2020; doi: 10.1016/S1473-3099(20)30796-9. - DOI - PubMed
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- Wunderink RG, Matsunaga Y, Ariyasu M, et al. Cefiderocol versus high-dose, extended-infusion meropenem for the treatment of Gram-negative nosocomial pneumonia (APEKS-NP): a randomised, double-blind, phase 3, non-inferiority trial. Lancet Infect Dis 2020; doi: 10.1016/S1473-3099(20)30731-3. - DOI - PubMed
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