 | |
| Clinical data | |
|---|---|
| Trade names | Rezzayo |
| Other names | Biafungin; CD101 |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a623021 |
| License data |
|
| 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.[2] It is an echinocandin antifungal.[1][4]
Rezafungin was approved for medical use in the United States in March 2023,[1][5][6] and in the European Union in December 2023.[2][3]
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Transcription
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.[2]
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.[2] The applicant for this medicinal product is Mundipharma GmbH.[2] Rezafungin was approved for medical use in the European Union in December 2023.[3]
Brand names
Rezafungin is the international nonproprietary name.[10]
Rezafungin is sold under the brand name Rezzayo.[2]
References
- ^ a b c d e "Rezzayo- rezafungin injection, powder, lyophilized, for solution". DailyMed. 8 June 2023. Retrieved 26 December 2023.
- ^ a b c d e f g "Rezzayo EPAR". European Medicines Agency (EMA). 12 October 2023. Retrieved 27 December 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ a b c "Rezzayo Product information". Union Register of medicinal products. 22 December 2023. Retrieved 26 December 2023.
- ^ Zhao Y, Perlin DS (September 2020). "Review of the Novel Echinocandin Antifungal Rezafungin: Animal Studies and Clinical Data". Journal of Fungi. 6 (4): 192. doi:10.3390/jof6040192. PMC 7712954. PMID 32998224.
- ^ "Rezzayo approved by FDA amid rapid Candida auris spread". thepharmaletter.com. 23 March 2023.
- ^ Syed YY (June 2023). "Rezafungin: First Approval". Drugs. 83 (9): 833–840. doi:10.1007/s40265-023-01891-8. PMID 37212966. S2CID 258831091.
- ^ "Novel Drug Approvals for 2023". U.S. Food and Drug Administration (FDA). 22 December 2023. Retrieved 27 December 2023.
- ^ "Drug Approval Package: Rezzayo". U.S. Food and Drug Administration (FDA). 18 April 2023. Retrieved 27 December 2023.
- ^ New Drug Therapy Approvals 2023 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2024. Archived from the original on 10 January 2024. Retrieved 9 January 2024.
- ^ World Health Organization (2018). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 79". WHO Drug Information. 32 (1). hdl:10665/330941.
External links
- "Rezafungin Injection". U.S. Food and Drug Administration. 18 April 2023.
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This page was last edited on 24 March 2024, at 14:22