FDA Advisory Committee recommends approval of rezafungin for the treatment of candidemia and invasive candidiasis
Cidara Therapeutics, Inc. and Melinta Therapeutics, LLC announced that the FDA Antimicrobial Drugs Advisory Committee voted favorably 14 to 1 that Cidara, as part of its New Drug Application (NDA), 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 Cidara’s global ReSTORE Phase III trial and supported by the STRIVE Phase II clinical trials and extensive non-clinical development program. Rezafungin dosed once-weekly demonstrated statistical non-inferiority versus caspofungin, the current standard of care, dosed once-daily, meeting the primary endpoints for both the FDA and the European Medicines Agency (EMA)
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