{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T20:10:05Z","timestamp":1791576605583,"version":"4.3.4"},"reference-count":27,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2022,10,4]],"date-time":"2022-10-04T00:00:00Z","timestamp":1664841600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2023,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>The US Food and Drug Administration is committed to the development of effective antiviral regimens for pediatric patients with coronavirus disease 2019 (COVID\u201019), including infants and neonates. On April 25, 2022, the approved indication of remdesivir (RDV) was expanded to include pediatric patients 28 days and older and weighing at least 3 kg with positive results of direct severe acute respiratory syndrome coronavirus 2 viral testing, who are:\n<jats:list list-type=\"bullet\">\n<jats:list-item><jats:p>Hospitalized, or<\/jats:p><\/jats:list-item>\n<jats:list-item><jats:p>Not hospitalized and have mild to moderate COVID\u201019 and are at high risk for progression to severe COVID\u201019, including hospitalization or death.<\/jats:p><\/jats:list-item><\/jats:list><\/jats:p><jats:p>Given the similar course of COVID\u201019 in adults and pediatric patients, the approval of RDV for use in pediatric patients is supported by the safety and efficacy data from adequate and well\u2010controlled phase 3 trials in adults and adolescents; and by the safety and pharmacokinetic data from a single\u2010arm, open\u2010label, phase 2\/3 pediatric clinical trial of 53 pediatric patients at least 28 days of age and weighing at least 3 kg with confirmed severe acute respiratory syndrome coronavirus 2 infection and mild, moderate, or severe COVID\u201019. At the time of the April 25, 2022, approval action, the US Food and Drug Administration also revoked the emergency use authorization for RDV that previously covered this pediatric population. This article summarizes key issues and regulatory considerations involved in the RDV COVID\u201019 pediatric development program, including the evolution of the emergency use authorization issued for RDV as results from registrational studies became available, and discusses lessons learned.<\/jats:p>","DOI":"10.1002\/jcph.2158","type":"journal-article","created":{"date-parts":[[2022,9,23]],"date-time":"2022-09-23T18:16:38Z","timestamp":1663956998000},"page":"259-265","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Considerations and Challenges in the Remdesivir COVID\u201019 Pediatric Development Program"],"prefix":"10.1002","volume":"63","author":[{"given":"Kirk","family":"Chan\u2010Tack","sequence":"first","affiliation":[{"name":"Division of Antivirals, Office of Infectious Diseases, Center for Drug Evaluation and Research Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mario","family":"Sampson","sequence":"additional","affiliation":[{"name":"Division of Infectious Disease Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Justin","family":"Earp","sequence":"additional","affiliation":[{"name":"Division of Infectious Disease Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vikram","family":"Arya","sequence":"additional","affiliation":[{"name":"Division of Infectious Disease Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lynne","family":"Yao","sequence":"additional","affiliation":[{"name":"Division of Pediatric and Maternal Health, Center for Drug Evaluation and Research Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Alexander","sequence":"additional","affiliation":[{"name":"Division of Pediatric and Maternal Health, Center for Drug Evaluation and Research Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ethan","family":"Hausman","sequence":"additional","affiliation":[{"name":"Division of Pediatric and Maternal Health, Center for Drug Evaluation and Research Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yodit","family":"Belew","sequence":"additional","affiliation":[{"name":"Division of Antivirals, Office of Infectious Diseases, Center for Drug Evaluation and Research Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Debra","family":"Birnkrant","sequence":"additional","affiliation":[{"name":"Division of Antivirals, Office of Infectious Diseases, Center for Drug Evaluation and Research Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kimberly","family":"Struble","sequence":"additional","affiliation":[{"name":"Division of Antivirals, Office of Infectious Diseases, Center for Drug Evaluation and Research Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2022,10,4]]},"reference":[{"key":"e_1_2_11_2_1","unstructured":"Code of Federal Regulations Title 21 \u00a7 360bbb\u20103. Authorization for medical products for use in emergencies.https:\/\/www.govinfo.gov\/content\/pkg\/USCODE-2020-title21\/pdf\/USCODE-2020-title21-chap9-subchapV-partEsec360bbb-3.pdf. Accessed June 29 2022."},{"key":"e_1_2_11_3_1","unstructured":"Emergency Use Authorization issuance of remdesivir for certain COVID\u201019 patients. Issued: May 1 2020. Reissued: August 28 2020 October 1 2020 October 22 2020 January 21 2022.https:\/\/www.fda.gov\/media\/137564\/download;https:\/\/www.fda.gov\/media\/137565\/download;https:\/\/www.fda.gov\/media\/137566\/download. Revoked April 25 2022. Accessed June 29 2022."},{"key":"e_1_2_11_4_1","unstructured":"Center for Drug Evaluation and Research.Approval Package and Reviews for NDA 214787; action date October 22 2020.https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/nda\/2020\/214787Orig1s000TOC.cfm. 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Accessed June 29 2022."},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1910993"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1126\/scitranslmed.aal3653"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1073\/pnas.1922083117"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41422-020-0282-0"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2007764"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2015301"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2020.16349"},{"key":"e_1_2_11_15_1","unstructured":"EMA provides recommendations on compassionate use of remdesivir for COVID\u201019.https:\/\/www.ema.europa.eu\/en\/documents\/other\/summary\u2010compassionate\u2010use\u2010remdesivir\u2010gilead_en.pdf. Published April 3 2020. 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Accessed June 29 2022."}],"container-title":["The Journal of Clinical Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcph.2158","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/jcph.2158","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcph.2158","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,20]],"date-time":"2023-08-20T22:41:56Z","timestamp":1692571316000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/jcph.2158"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,10,4]]},"references-count":27,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2023,2]]}},"alternative-id":["10.1002\/jcph.2158"],"URL":"https:\/\/doi.org\/10.1002\/jcph.2158","archive":["Portico"],"relation":{},"ISSN":["0091-2700","1552-4604"],"issn-type":[{"value":"0091-2700","type":"print"},{"value":"1552-4604","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,10,4]]},"assertion":[{"value":"2022-07-06","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-09-13","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-10-04","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}