{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T23:23:14Z","timestamp":1787008994491,"version":"build-2736575974"},"reference-count":22,"publisher":"Oxford University Press (OUP)","issue":"2","license":[{"start":{"date-parts":[[2024,3,19]],"date-time":"2024-03-19T00:00:00Z","timestamp":1710806400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,8,16]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>On 22 March 2023, the FDA approved rezafungin (Rezzayo) for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options. Rezafungin is an echinocandin that supports weekly dosing, enabling outpatient parenteral treatment that potentially avoids the need for a central venous catheter. Approval of rezafungin was based on a single adequate and well-controlled phase 3 study designed with a day 30 all-cause mortality primary end point and 20% noninferiority margin, which demonstrated that rezafungin is noninferior to the comparator echinocandin. Nonclinical studies of rezafungin in nonhuman primates identified a neurotoxicity safety signal; however, rezafungin's safety profile in the completed clinical studies was similar to other Food and Drug Administration-approved echinocandins. Here we describe the rationale for this approval and important considerations during the review process for a flexible development program intended to expedite the availability of antimicrobial therapies to treat serious infections in patients with limited treatment options.<\/jats:p>\n                  <jats:p>Clinical Trials Registration . NCT02734862 and NCT03667690.<\/jats:p>","DOI":"10.1093\/infdis\/jiae146","type":"journal-article","created":{"date-parts":[[2024,3,18]],"date-time":"2024-03-18T10:57:44Z","timestamp":1710759464000},"page":"505-513","source":"Crossref","is-referenced-by-count":19,"title":["Regulatory Considerations in the Approval of Rezafungin (Rezzayo) for the Treatment of Candidemia and Invasive Candidiasis in Adults"],"prefix":"10.1093","volume":"230","author":[{"given":"Heidi L","family":"Smith","sequence":"first","affiliation":[{"name":"Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration , Silver Spring, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Timothy J","family":"Bensman","sequence":"additional","affiliation":[{"name":"Division of Infectious Disease Pharmacology, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration , Silver Spring, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shrimant","family":"Mishra","sequence":"additional","affiliation":[{"name":"Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration , Silver Spring, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xianbin","family":"Li","sequence":"additional","affiliation":[{"name":"Division of Biometrics IV, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration , Silver Spring, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cheryl A","family":"Dixon","sequence":"additional","affiliation":[{"name":"Division of Biometrics IV, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration , Silver 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Silver Spring, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhixia Y","family":"Danielsen","sequence":"additional","affiliation":[{"name":"Division of Infectious Disease Pharmacology, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration , Silver Spring, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0879-3450","authenticated-orcid":false,"given":"Irum","family":"Syed","sequence":"additional","affiliation":[{"name":"DRT Strategies, Inc , Arlington, Virginia , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sunita J","family":"Shukla","sequence":"additional","affiliation":[{"name":"Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration , Silver Spring, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dmitri","family":"Iarikov","sequence":"additional","affiliation":[{"name":"Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration , Silver Spring, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter W","family":"Kim","sequence":"additional","affiliation":[{"name":"Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration , Silver Spring, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John J","family":"Farley","sequence":"additional","affiliation":[{"name":"Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration , Silver Spring, Maryland , 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