Cidara: FDA Committee Recommends FDA Approve Rezafungin For Candidemia, Invasive Candidiasis

Cidara Therapeutics, Inc. (CDTX) and Melinta Therapeutics announced the FDA Antimicrobial Drugs Advisory Committee voted favorably 14 to 1 that Cidara, as part of its New Drug Application, provided sufficient evidence supporting a favorable benefit-risk assessment for a limited use indication for rezafungin for the treatment of candidemia and invasive candidiasis in adult patients with limited or no alternative treatment options. The Committee's positive vote was based on clinical data from the ReSTORE Phase 3 and supported by the STRIVE Phase 2 trials and non-clinical development program.

Cidara's NDA for rezafungin was accepted for filing and granted Priority Review by the FDA on September 20, 2022. The FDA has assigned a PDUFA target action date of March 22, 2023.

In 2022, Melinta acquired the exclusive rights to commercialize rezafungin in the U.S. from Cidara.

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