Cidara Therapeutics submits NDA for rezafungin and announces license agreement with Melinta Therapeutics for commercialization of rezafungin in the USA.
Cidara Therapeutics, Inc. announced that it has submitted a New Drug Application (NDA) to the FDA for rezafungin for the treatment of candidemia and invasive candidiasis. The company also announced that it has entered into a license agreement with Melinta Therapeutics under which Cidara has granted Melinta an exclusive license to commercialize rezafungin in the U.S.
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 transplantation.
Cidara submitted the NDA for rezafungin for candidemia and invasive candidiasis, for which no new therapies have been approved in over a decade, to the FDA on July 22, 2022. The FDA has previously granted Qualified Infectious Disease Product (QIDP) designation to rezafungin for injection which confers priority review of the NDA. Additionally, the treatment indication has orphan designation. Cidara expects to be assigned a Prescription Drug User Fee Act (PDUFA) target action date in the first quarter of 2023, if the NDA is accepted for review following application validation.
The NDA submission for rezafungin was based on positive results from Cidara’s global ReSTORE Phase III and STRIVE Phase II trials. ReSTORE met the primary endpoints for both the FDA and the European Medicines Agency (EMA). Rezafungin dosed once-weekly demonstrated statistical non-inferiority versus caspofungin, the current standard of care, dosed once-daily.
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