The approval was based on clinical data from the global ReSTORE phase 3 trial and is also backed by the STRIVE phase 2 clinical trial and a non-clinical development programme
Cidara Therapeutics and Melinta Therapeutics have received approval for REZZAYO (rezafungin for injection) from the US Food and Drug Administration (FDA) for the treatment of candidemia and invasive candidiasis.
The FDA has approved the antifungal drug to treat infections in patients 18 years of age or older with limited or no alternative treatment options.
REZZAYO is a once-weekly, next-generation echinocandin. Its structure and properties are designed specifically to improve upon a mechanism that is clinically validated.
Its approval is based on clinical data from Cidara Therapeutics’ global ReSTORE phase 3 trial. It is also backed by the STRIVE phase 2 trial and a non-clinical development programme.
Cidara Therapeutics said that REZZAYO met the FDA and European Medicines Agency (EMA) primary endpoints in the clinical studies. The drug showed statistical non-inferiority when compared with caspofungin, an existing once-daily standard of care.
Additionally, the overall rates of adverse events and serious adverse events were similar in patients receiving the investigational drug candidate and caspofungin.
Furthermore, rates of adverse events that led to the discontinuation of the study drug were also comparable for both candidates.
Cidara Therapeutics president and CEO Jeffrey Stein said: “The FDA approval of REZZAYO represents a significant milestone for Cidara, and for patients confronted with difficult-to-treat and often deadly candidemia and invasive candidiasis.
“I am extremely proud of all of the Cidara employees who collectively advanced REZZAYO from preclinical development to NDA approval and am grateful to the many patients and healthcare teams who have participated in the clinical studies.”
REZZAYO was cleared under priority review based on the Qualified Infectious Disease Product (QIDP) designation.
In 2022, Melinta Therapeutics acquired the exclusive rights to market the antifungal drug candidate in the US from Cidara Therapeutics. The latter retains the rights to rezafungin in Japan.
The EMA accepted rezafungin’s marketing authorisation application (MAA) in August 2022 and it is presently under review.