NewsDesk @bactiman63

On Monday, the CDC reported an increasing threat of the emerging fungus Candida auris. Today, the U.S. FDA today approved Cidara Therapeutics and Melinta Therapeutics’ REZZAYOTM (rezafungin for injection), a novel once-weekly echinocandin, for the treatment of candidemia and invasive candidiasis in adults 18 years of age or older who have limited or no alternative treatment options.


This is the first new FDA-approved echinocandin in over a decade.

Over 90% of invasive fungal infections begin in the hospital, with infections caused by the Candida fungus – candidemia and invasive candidiasis – comprising the majority of these potentially deadly infections. Current treatments have significant limitations including toxicities, drug-drug interactions, daily IV administration or increasing resistance to treatments. As a once-weekly injection, REZZAYO has the potential to simplify the management of candidemia and invasive candidiasis and address unmet medical needs for patients.  

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Clinical data from Cidara’s global ReSTORE Phase 3 trial showed that REZZAYO, dosed once-weekly, met the FDA and EMA primary endpoints demonstrating statistical non-inferiority versus caspofungin, a current once-daily standard of care. Safety data for REZZAYO was also comparable to caspofungin. 

Melinta Therapeutics has the exclusive rights to commercialize REZZAYO in the U.S. and the company anticipates bringing the drug to patients this summer.