Mundipharma and Cidara Therapeutics have received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for rezafungin (rezafungin acetate) to treat invasive candidiasis in adult patients.
Invasive candidiasis is a severe infection of the bloodstream and/or deep or visceral tissues.
The positive opinion is based on data from the pivotal ReSTORE Phase III clinical study.
It showed statistical non-inferiority for one weekly dose of rezafungin against the current standard of care, caspofungin, which is given daily.
The STRIVE Phase II clinical trials and a nonclinical development programme supported this finding.
The ReSTORE trial demonstrated that rezafungin shows both efficacy and safety and is therefore a potential new treatment for invasive candidiasis,
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Mundipharma chief scientific officer Brian Sheehan stated: “We would like to thank the CHMP for their careful consideration of the use of rezafungin.
“This positive opinion represents an important step on the journey towards approval and brings us closer to providing clinicians with an alternative treatment option for invasive candida infections, giving hope to patients battling this infection and their families.”
Cidara Therapeutics has teamed up with Mundipharma, which holds commercial rights to rezafungin outside Japan and the US.
Cidara is carrying out the second Phase III clinical study of rezafungin, ReSPECT, to prevent invasive fungal disease in patients undergoing allogeneic blood and marrow transplantation.
Rezafungin first received approval from the US Food and Drug Administration in March 2023 to treat candidemia and invasive candidiasis in individuals with limited or no alternative treatment options.