FDA Approves Antifungal Rezafungin to Treat Candidemia and Invasive Candidiasis

Last night, the US Food and Drug Administration (FDA) approved the injectable antifungal rezafungin to treat candidemia and invasive candidiasis in adults with few to no alternative treatment options.

The decision came late on rezafungin’s Presecription Drug User Fee Act (PDUFA) date of March 22, 2023, just days after the US Centers for Disease Control and Prevention (CDC) reported a concerning rise in Candida auris across the country.

With this approval, rezafungin become the first new drug approved to treat candidemia and invasive candidiasis in more than 10 years. Rezafungin was developed by Cidara Therapeutics, and it will be marketed by Melinta Therapeutics and Mundipharma under the name Rezzayo.

“We are extremely pleased that the FDA’s advisory committee has recommended that the FDA approve rezafungin for difficult-to-treat and often deadly candidemia and invasive candidiasis,” said Jeffrey Stein, PhD, president and CEO of Cidara. “This positive recommendation is a significant step towards our goal of providing a once-weekly treatment option for patients with invasive Candida infections, for which no new drugs have been approved in over a decade. We believe rezafungin, if approved, could provide an effective new alternative for patients battling these potentially deadly diseases.”

The yeast Candida causes fungal infections if it grows unmitigated or enter deep into the body. Left untreated, Candida can cause infections in the bloodstream or the kidney, heart, brain, and other internal organs.

Candidemia and invasive candidiasis are infections that can affect multiple parts of the body after Candida spreads. Candidemia in particular is a common infection in hospitalized patients.

Rezafungin is a once-weekly, next-generation echinocandin. The FDA’s affirmative decision was largely based on positive data from phase 3 clinical trials. Dosed once a week, rezafungin was determined to be statistically noninferior compared to once-daily caspofungin, the current standard of care. Rexafungin met the primary trial endpoints for the FDA and the European Medicines Agency (EMA).

Melinta Therapeutics announced injectable rezafungin (Rezzayo) will be available summer 2023.

“The Committee’s robust discussion was an important step in the FDA’s review of rezafungin,” said Christine Ann Miller, president and CEO of Melinta Therapeutics. “We are pleased that the committee recognized the unmet need that rezafungin will address in the treatment of candidemia and invasive candidiasis. We remain committed to working closely with our partner Cidara in securing FDA approval of rezafungin.”