Chemistry:Rezafungin
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| Clinical data | |
|---|---|
| Trade names | Rezzayo |
| Other names | Biafungin; CD101 |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a623021 |
| License data |
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| Routes of administration | Intravenous |
| Drug class | Antifungal |
| ATC code | |
| Legal status | |
| Legal status | |
| Pharmacokinetic data | |
| Excretion | Feces |
| Identifiers | |
| CAS Number | |
| PubChem CID | |
| DrugBank | |
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C63H85N8O17+ |
| Molar mass | 1226.412 g·mol−1 |
Rezafungin, sold under the brand name Rezzayo, is a medication used for the treatment of invasive candidiasis. It is an echinocandin antifungal.[1][3]
Rezafungin was approved for medical use in the United States in March 2023,[1][4][5] and in the European Union in December 2023.[2]
Medical uses
In the United States, rezafungin is indicated indicated in adults who have limited or no alternative options for the treatment of candidemia and invasive candidiasis.[1]
In the European Union, rezafungin is indicated for the treatment of invasive candidiasis in adults.[6]
Society and culture
Legal status
Rezafungin was approved for medical use in the United States in March 2023,[1][7][8] The FDA granted the application for rezafungin orphan drug, fast track, and priority review designations.[9]
In October 2023, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Rezzayo, intended for the treatment of invasive candidiasis in adults.[6] The applicant for this medicinal product is Mundipharma GmbH.[6] Rezafungin was approved for medical use in the European Union in December 2023.[2]
Brand names
Rezafungin is the international nonproprietary name.[10]
Rezafungin is sold under the brand name Rezzayo.[6]
References
- ↑ 1.0 1.1 1.2 1.3 1.4 "Rezzayo- rezafungin injection, powder, lyophilized, for solution". 8 June 2023. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=90073508-6dca-4d27-aa5a-ed837737c35b.
- ↑ 2.0 2.1 2.2 "Rezzayo Product information". 22 December 2023. https://ec.europa.eu/health/documents/community-register/html/h1775.htm.
- ↑ "Review of the Novel Echinocandin Antifungal Rezafungin: Animal Studies and Clinical Data". Journal of Fungi 6 (4): 192. September 2020. doi:10.3390/jof6040192. PMID 32998224.
- ↑ "Rezzayo approved by FDA amid rapid Candida auris spread". March 23, 2023. https://www.thepharmaletter.com/article/rezzayo-approved-by-fda-amid-rapid-candida-auris-spread.
- ↑ "Rezafungin: First Approval". Drugs 83 (9): 833–840. June 2023. doi:10.1007/s40265-023-01891-8. PMID 37212966. https://figshare.com/articles/online_resource/Rezafungin_First_Approval/22756766.
- ↑ 6.0 6.1 6.2 6.3 "Rezzayo EPAR". 12 October 2023. https://www.ema.europa.eu/en/medicines/human/EPAR/rezzayo. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ↑ "Novel Drug Approvals for 2023". 22 December 2023. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2023.
- ↑ "Drug Approval Package: Rezzayo". 18 April 2023. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/217417Orig1s000TOC.cfm.
- ↑ (PDF) New Drug Therapy Approvals 2023 (Report). January 2024. https://www.fda.gov/media/175253/download. Retrieved 9 January 2024.
- ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 79". WHO Drug Information 32 (1). 2018.
External links
- "Rezafungin Injection". 18 April 2023. https://www.fda.gov/drugs/development-resources/rezafungin-injection.
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