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# Cidar/Melinta’s Rezzayo Wins FDA Approval
- URL: https://www.fdaweb.com/cidar-melintas-rezzayo-wins-fda-approval/
- Published: 2023-03-23T12:00:00.000Z
- Updated: 2026-09-14T18:21:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154059

FDA has approved a Cidara Therapeutics and Melinta Therapeutics NDA for Rezzayo (rezafungin for injection) for treating candidemia and invasive candidiasis in adults with limited or no alternative treatment options. The companies say this is the first new treatment option approved for these conditions in over a decade.

Approval was based on clinical data from Cidara’s global ReSTORE Phase 3 trial and supported by the STRIVE Phase 2 clinical trial. The studies demonstrated statistical non-inferiority versus caspofungin, the current standard of care, the companies say. In addition, adverse events and serious adverse events were comparable in patients receiving Rezzayo and caspofungin.

The companies say the drug is also currently being studied for the prevention of invasive fungal diseases in adults undergoing allogeneic blood and marrow transplantation.