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# Panel Votes to Approve Cidara’s Rezafungin
- URL: https://www.fdaweb.com/panel-votes-to-approve-cidaras-rezafungin/
- Published: 2023-01-25T12:00:00.000Z
- Updated: 2026-09-14T18:13:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153623

FDA’s Antimicrobial Drugs Advisory Committee has voted 14 to 1 to recommend that a Cidara Therapeutics NDA for rezafungin demonstrated a favorable benefit-risk profile for a limited use indication in treating candidemia and invasive candidiasis in adult patients with limited or no alternative treatment options. The submission has a user fee review action target date of 3/22.

An FDA [briefing document](https://www.fda.gov/media/164666/download?ref=fdaweb.com) released in advance of the panel meeting showed that reviewers found the company’s single Phase 3 study demonstrated rezafungin’s noninferiority to caspofungin (Merck’s Cancidas), but it did not agree with the company’s proposal in the NDA to “pool the efficacy data from the Phase 2 and Phase 3 studies to support the proposed indication. In addition, a neurotoxicity signal was identified in nonclinical studies of rezafungin in nonhuman primates.”

The briefing document agreed that rezafungin has an extended half-life that supports once-weekly intravenous (IV) dosing, which it saw as a benefit over other FDA-approved therapies in the same drug class (echinocandins), which require daily IV dosing. It also noted that Cidara’s position is that rezafungin “may also have antimicrobial and pharmacologic properties that differentiate it from other FDA-approved echinocandins, such as improved in vitro activity against isolates with reduced susceptibility to some echinocandins, higher probability of target attainment (PTA), and improved tissue penetration,” but the agency said that currently in the review it does not believe the company has provided sufficient data to support this position.

It has been over a decade since a new drug has been approved for treating invasive *Candida* infections, according to the company. “We believe rezafungin, if approved, could provide an effective new alternative for patients battling these potentially deadly diseases,” it says.