Melinta Therapeutics, LLC and Cidara Therapeutics, Inc. announced the peer-reviewed publication of pooled data from two completed global clinical trials evaluating REZZAYO®? (rezafungin for injection) for the treatment of candidemia and invasive candidiasis. The article, "Efficacy and safety of rezafungin and caspofungin in candidemia and invasive candidiasis: pooled data from two prospective randomised controlled trials," published in The Lancet Infectious Diseases, reports on pooled data analyses of the pivotal ReSTORE Phase 3 randomized controlled clinical trial, which demonstrated the non-inferiority of rezafungin versus caspofungin for all-cause mortality and with similar safety profiles and provide additional evidence for potential early treatment benefits.

The ReSTORE pivotal Phase 3 trial demonstrated that REZZAYO met the primary endpoint for the U.S. Food and Drug Administration (FDA) New Drug Application (NDA) submission of all-cause mortality at Day 30, and also met the primary endpoint for the European Medicines Agency (EMA) Marketing Authorization Application (MAA) submission of global cure at Day 14. The STRIVE Phase 2 study provided safety and supportive efficacy data on REZZAYO. REZZAYO was generally well tolerated and had a similar safety profile to caspofungin.

On March 22, 2023, the FDA approved REZZAYO for the treatment of candidemia & invasive candidiasis in adults with limited or no alternative treatment options. REZZAYO is the first new treatment option approved for patients with candidemia and invasive candidiasis in over fifteen years. The Centers for Medicare & Medicaid Services (CMS) issued a permanent product-specific J-Code (J0349, Injection, rezafungin, 1 mg) for REZZAYO injection effective October 1, 2023.

CMS also granted a new technology add-on payment (NTAP) for REZZAYO for eligible participating hospitals when Medicare patients are treated in the inpatient acute care hospital setting. Last year, Melinta announced that it had acquired the exclusive rights to commercialize rezafungin in the U.S. from Cidara. Advise patients to use protection from sun exposure and other sources of UV radiation.

Abnormalities in liver tests have been seen in clinical trial patients treated with REZZAYO. Monitor patients who develop abnormal liver tests and evaluate patients for their risk/benefit of continuing REZZAYO therapy.