The FDA's advisory committee on antimicrobial drugs on Jan. 25 recommended rezafungin be approved to treat candidemia and invasive candidiasis in adults with limited or no alternative treatment option.
If approved, it would mark the first new drug approval to treat the infections in more than a decade, according to Cidara Therapeutics, which developed the drug. The FDA panel's 14 to 1 vote to recommend rezafungin was based on results from phase 2 and 3 clinical trials, as well as extensive nonclinical findings. The once-weekly treatment demonstrated statistical non-inferiority when compared to caspofungin, the current standard of care given once daily.
The advisory committee's vote is not binding, though the FDA usually accepts the recommendations in its drug approval decisions.
Cidara has a licensing agreement with Melinta Therapeutics to commercialize the drug in the U.S.