Rezzayo

The approval was based on data from the randomized, double-blind phase 3 ReSTORE study (ClinicalTrials.gov Identifier: NCT03667690), which included 187 adults diagnosed with candidemia and/or invasive candidiasis.

Treatment with rezafungin was found to be noninferior to caspofungin for the primary endpoint of all-cause mortality at day 30, using a 20% noninferiority margin. The trial provided evidence for efficacy to support an indication with a limited use statement, given the wider noninferiority margin. All-cause mortality at day 30 was reported to be 23.7% for the rezafungin group and 21.3% for the caspofungin group (treatment difference, 2.4% [95% CI, -9.7, 14.4]).

The approval was also supported by safety and efficacy data from the double-blind, randomized, phase 2 STRIVE study (ClinicalTrials.gov Identifier: NCT02734862). The primary objectives of this study were to evaluate safety and tolerability of rezafungin and overall success (mycological eradication and resolution of systemic signs attributable to candidemia and/or invasive candidiasis) at day 14. The study provided safety and supportive efficacy data.