The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for rezafungin, a novel once-weekly echinocandin antifungal, for the treatment of candidemia and invasive candidiasis.
The NDA includes 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. Additionally, a greater proportion of patients treated with rezafungin achieved mycologic eradication at day 5 and 14 compared with caspofungin.
The application is also supported by positive data from the double-blind, randomized, phase 2 STRIVE study (ClinicalTrials.gov Identifier: NCT02734862).
“Today’s announcement is an important step forward for patients fighting difficult-to-treat and often deadly candidemia and invasive candidiasis, and represents a critical milestone for Cidara’s rezafungin development program,” said Jeff Stein, President, and CEO of Cidara Therapeutics. “The data generated across our phase 2 and phase 3 trials demonstrated that rezafungin could transform the current standard of care for the treatment of invasive Candida infections, and we are excited that rezafungin could potentially be the first new drug approved for this indication in over a decade.”
A Prescription Drug User Fee Act target action date of March 22, 2023 has been set for the application.
Cidara Therapeutics announces FDA acceptance for Priority Review of New Drug Application for rezafungin for the treatment of candidemia and invasive candidiasis. News release. Cidara Therapeutics, Inc. Accessed September 21, 2022. https://www.globenewswire.com/news-release/2022/09/20/2519691/35407/en/Cidara-Therapeutics-Announces-FDA-Acceptance-for-Priority-Review-of-New-Drug-Application-for-Rezafungin-for-the-Treatment-of-Candidemia-and-Invasive-Candidiasis.html