Cidara Therapeutics and Mundipharma have announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for rezafungin in the treatment of invasive candidiasis in adults.
Successful Phase III Clinical Trial Results
The CHMP’s decision was based on the results of a Phase III clinical trial, which showed that rezafungin, administered once weekly, was statistically non-inferior to caspofungin, the current standard of care administered once daily.
A New Option for Treating Invasive Candidiasis
The trial provided compelling evidence of rezafungin’s efficacy and safety as a potential new treatment option for invasive candidiasis. Notably, rezafungin’s once-weekly dosing schedule offers convenience and ease of administration.
Understanding Invasive Candidiasis
Invasive candidiasis is a severe and life-threatening infection that affects the bloodstream and/or deep/visceral tissues. Finding effective treatments is crucial in combating this dangerous condition.
The CHMP’s positive opinion on rezafungin will now be referred to the European Commission, which is expected to make a final decision within approximately two months. This decision holds great significance as it has the potential to bring rezafungin closer to patients in need.
Outside of the United States and Japan, Mundipharma holds the commercial rights for rezafungin. This partnership ensures broader global accessibility to this promising treatment option.