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]
^ abcdefg"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.
^World Health Organization (2018). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 79". WHO Drug Information. 32 (1). hdl:10665/330941.
