EU regulator to review novel antifungal for deadly infection

22 August 2022

A regulatory submission from British firm Mundipharma, for the invasive candidiasis (IC) candidate rezafungin, has been accepted for review by the European Medicines Agency.

Developed by USA-based Cidara Therapeutics (Nasdaq: CDTX), the candidate is backed by positive results from the Phase III ReSTORE trial, which showed non-inferiority compared to the current standard of care, caspofungin.

There is a high level of unmet medical need in the treatment of IC, a severe, life-threatening systemic infection which particularly affects critically ill people in hospitals and those with a compromised immune system.

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