JANUARY 26, 2023

Rezafungin Receives Nod From FDA Antimicrobial Drugs Advisory Committee

By Landon Gray

In a 14-0 vote, the FDA’s Antimicrobial Drugs Advisory Committee recommended approval for rezafungin (Cidara Therapeutics/Melinta Therapeutics) to treat candidemia and invasive candidiasis.

Rezafungin is a novel, once-weekly echinocandin developed for the treatment and prevention of serious fungal infections, including candidemia and invasive candidiasis.

The companies provided clinical data from the phase 3 ReSTORE and phase 2 STRIVE trials to the committee. Built from the