Cidara Therapeutics, Inc. , a biotechnology company developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases, announced the FDA acceptance for filing and granted Priority Review to its New Drug Application (NDA) for rezafungin for the treatment of candidemia and invasive candidiasis. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 22, 2023 enabled by rezafungin’s designation as a Qualified Infectious Disease Product (QIDP) and has indicated that it is currently planning to hold an advisory committee meeting to discuss the application. QIDP designation is reserved for antibacterial and antifungal drug candidates intended to treat serious or life-threatening infections. Rezafungin is a novel, once-weekly echinocandin antifungal being developed for the treatment of candidemia and invasive candidiasis, as well as for the prophylaxis of invasive fungal infections in patients undergoing allogeneic blood and marrow transplant.
“Today’s announcement is an important step forward for patients fighting difficult-to-treat and often deadly candidemia and invasive candidiasis, and represents a critical milestone for Cidara’s rezafungin development program,” said Jeff Stein, President, and CEO of Cidara Therapeutics. “The data generated across our Phase 2 and Phase 3 trials demonstrated that rezafungin could transform the current standard of care for the treatment of invasive Candida infections, and we are excited that rezafungin could potentially be the first new drug approved for this indication in over a decade.”
The NDA submission for rezafungin was supported by positive clinical data from the global ReSTORE Phase 3 and STRIVE Phase 2 clinical trials. 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).
Cidara retains the rights to rezafungin in Japan and has licensed the commercial rights to Melinta Therapeutics in the U.S. and Mundipharma Medical in all other geographies.
