Rezafungin Explained

Tradename:Rezzayo
Dailymedid:Rezafungin
Routes Of Administration:Intravenous
Class:Antifungal
Atc Prefix:J02
Atc Suffix:AX08
Legal Us:Rx-only
Legal Us Comment:[1]
Legal Eu:Rx-only
Legal Eu Comment:[2]
Excretion:Feces
Cas Number:1396640-59-7
Pubchem:78318119
Unii:G013B5478J
Drugbank:16310
Kegg:D11197
Chebi:229680
Synonyms:Biafungin; CD101
C:63
H:85
N:8
O:17
Charge:+

Rezafungin, sold under the brand name Rezzayo, is a medication used for the treatment of invasive candidiasis. It is an echinocandin antifungal.[3]

Rezafungin was approved for medical use in the United States in March 2023,[4] [5] and in the European Union in December 2023.

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.

In the European Union, rezafungin is indicated for the treatment of invasive candidiasis in adults.

Society and culture

Legal status

Rezafungin was approved for medical use in the United States in March 2023,[6] [7] The FDA granted the application for rezafungin orphan drug, fast track, and priority review designations.[8]

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. The applicant for this medicinal product is Mundipharma GmbH.[9] Rezafungin was approved for medical use in the European Union in December 2023.

Brand names

Rezafungin is the international nonproprietary name.[10]

Rezafungin is sold under the brand name Rezzayo.

External links

Notes and References

  1. Web site: Rezzayo- rezafungin injection, powder, lyophilized, for solution . DailyMed . 8 June 2023 . 26 December 2023.
  2. Web site: Rezzayo Product information . Union Register of medicinal products . 22 December 2023 . 26 December 2023.
  3. Zhao Y, Perlin DS . Review of the Novel Echinocandin Antifungal Rezafungin: Animal Studies and Clinical Data . Journal of Fungi . 6 . 4 . 192 . September 2020 . 32998224 . 10.3390/jof6040192 . 7712954 . free .
  4. News: Rezzayo approved by FDA amid rapid Candida auris spread . March 23, 2023 . thepharmaletter.com .
  5. Syed YY . Rezafungin: First Approval . Drugs . 83 . 9 . 833–840 . June 2023 . 37212966 . 10.1007/s40265-023-01891-8 . 258831091 .
  6. Web site: Novel Drug Approvals for 2023 . U.S. Food and Drug Administration (FDA) . 22 December 2023 . 27 December 2023.
  7. Web site: Drug Approval Package: Rezzayo . U.S. Food and Drug Administration (FDA) . 18 April 2023 . 27 December 2023.
  8. New Drug Therapy Approvals 2023 . U.S. Food and Drug Administration (FDA) . January 2024 . PDF . 9 January 2024 . https://web.archive.org/web/20240110032419/https://www.fda.gov/media/175253/download . 10 January 2024 . live .
  9. Web site: Rezzayo EPAR . European Medicines Agency (EMA) . 12 October 2023 . 27 December 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  10. ((World Health Organization)) . 2018 . International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 79 . WHO Drug Information . 32 . 1 . 10665/330941 . free . World Health Organization .

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