FDA approves Rezzayo for candidemia and invasive candidiasis

Rezzayo is the first new treatment option approved for patients with candidemia and invasive candidiasis in over a decade.

The FDA approval of once-weekly Rezzayo was based on clinical data from Cidara’s global ReSTORE Phase III trial and supported by the STRIVE Phase II clinical trial and extensive non-clinical development program. In clinical studies, Rezzayo, dosed once-weekly, met the FDA and EMA primary endpoints, demonstrating statistical non-inferiority versus caspofungin, a current once-daily standard of care. In addition, overall rates of adverse events and serious adverse events were comparable in patients receiving Rezzayo and caspofungin, while rates of adverse events leading to study drug discontinuation were also similar for Rezzayo and caspofungin. Based on Qualified Infectious Disease Product (QIDP) designation, Rezzayo was approved under Priority Review.

The FDA approval of once-weekly Rezzayo was based on clinical data from Cidara’s global ReSTORE Phase III trial and supported by the STRIVE Phase II clinical trial and extensive non-clinical development program. In clinical studies, over a decade.