FDA Advisory Committee Recommends Rezafungin for Candidemia and Invasive Candidiasis

If approved on its March PDUFA date, rezafungin could be the first new Candida treatment option in over a decade.

If approved on its March PDUFA date, rezafungin could be the first new Candida treatment option in over a decade.

This morning, Cidara Therapeutics, Inc. and Melinta Therapeutics, LLC announced the US Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee voted 14 to 1 that rezafungin be approved for the treatment of candidemia and invasive candidiasis in adult patients.

With the vote, the FDA’s advisory committee indicated rezafungin’s New Drug Application provided sufficient evidence supporting a favorable risk-benefit assessment of the therapy.

“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,” said Jeffrey Stein, PhD, the president and CEO of Cidara. “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.

On September 20, 2022, Cidara’s New Drug Application for rezafungin was accepted for filing and granted priority review. The next step toward rezafungin approval is a Prescription Drug User Fee Act (PDUFA) decision, current expected on March 22, 2023.

The Advisory Committee’s recommendation was largely due to positive data from the phase 3 ReSTORE and phase 2 STRIVE 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).

“We are pleased that the committee recognized the unmet need that rezafungin will address in the treatment of candidemia and invasive candidiasis,” said Christine Ann Miller, president and CEO of Melinta Therapeutics. “We remain committed to working closely with our partner Cidara in securing FDA approval of rezafungin. We also look forward to leveraging our established commercial infrastructure and experience in marketing infectious disease products, especially within the hospital and acute care settings, to make rezafungin available to healthcare providers and their patients, if approved.”

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