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 | |
ChEBI | |
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]
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]
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]
Rezafungin is the international nonproprietary name. [10]
Rezafungin is sold under the brand name Rezzayo. [2]