The Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee voted 14 to 1 that the benefits of rezafungin outweigh its potential risks in the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options.
Rezafungin is an investigational echinocandin antifungal that is administered once weekly. The panel’s vote was based on data from the randomized, double-blind phase 3 ReSTORE study (ClinicalTrials.gov Identifier: NCT03667690), which evaluated the efficacy and safety of rezafungin in 187 adults diagnosed with candidemia and/or invasive candidiasis.
Treatment with rezafungin was found to be noninferior to caspofungin for the primary endpoint of all-cause mortality at day 30, using a 20% noninferiority margin. The trial provided evidence for efficacy to support an indication with a limited use statement, given the wider noninferiority margin. Efficacy data from the double-blind, randomized, phase 2 STRIVE study (ClinicalTrials.gov Identifier: NCT02734862) was also included in the application.
The safety profile of rezafungin was observed to be similar to other FDA-approved echinocandins. A neurotoxicity safety signal was identified in nonclinical and clinical studies.
Although not bound by the committee’s recommendations, the FDA does take them into consideration when making decisions on approval. A Prescription Drug User Fee Act target date of March 22, 2023 has been set for the application.
- Cidara Therapeutics and Melinta Therapeutics announce FDA advisory committee recommends approval of rezafungin for the treatment of candidemia and invasive candidiasis. News release. January 25, 2023. https://www.globenewswire.com/news-release/2023/01/25/2595033/0/en/Cidara-Therapeutics-and-Melinta-Therapeutics-Announce-FDA-Advisory-Committee-Recommends-Approval-of-Rezafungin-for-the-Treatment-of-Candidemia-and-Invasive-Candidiasis.html.
- US Food and Drug Administration. Rezafungin for Injection. FDA Briefing Document. January 24, 2023. https://www.fda.gov/media/164666/download.