EU accepts filing of rezafungin for invasive candidiasis

The MAA is based on results from the pivotal ReSTORE Phase III clinical trial, which demonstrated statistical non-inferiority of rezafungin dosed once weekly when compared to the current standard of care, caspofungin, dosed once daily. This trial provides evidence of efficacy and safety of rezafungin as potential first-line treatment for candidemia and invasive candidiasis.

Rezafungin has already been granted Orphan Drug Designation for its use in the treatment of invasive candidiasis in both the EU and US. A New Drug Application was recently submitted to the FDA for the treatment of candidemia and invasive candidiasis the USA. The FDA has previously identified rezafungin as a Qualified Infectious Disease Product, which grants both Fast Track and Priority Review status.