The European Medicines Agency (EMA) has accepted Mundipharma’s marketing authorisation application for rezafungin for the treatment of invasive candidiasis in adult patients, the company announced.
The application is based on results from the pivotal ReSTORE phase 3 clinical trial, which showed ‘statistical non-inferiority’ of rezafungin dosed once-weekly compared to the current standard of care – caspofungin – dosed once-daily.
Invasive candidiasis is a severe, life-threatening systemic Candida infection of the bloodstream and/or deep or visceral tissues. Despite currently available treatments, the mortality rate for patients with invasive candidiasis remains high at up to 40%, underscoring the need for new treatment options.
Rezafungin is a next-generation, once-weekly echinocandin currently in development for both the treatment and prevention of serious fungal infections, such as invasive candidiasis and candidemia. The structure and properties of rezafungin are specifically designed to improve upon a clinically validated mechanism intended to enhance its efficacy and safety potential for patients.
Brian Sheehan, chief scientific officer at Mundipharma, said: “Rezafungin, as a next-generation echinocandin, represents the first advancement in the treatment of invasive Candida infections in a very long time. If approved, the treatment could bring new hope for critically ill, vulnerable patients battling with this deadly disease in the EU.
“We are pleased that the EMA has accepted our marketing authorisation application for rezafungin, and we look forward to working with the EMA to bring this medicine to patients.”
Mundipharma and Cidara Therapeutics (Cidara) announced a strategic partnership in 2019 to develop and commercialise rezafungin, which included an upfront of £30m from Mundipharma, an equity investment of $9m and up to $529m in milestone payments, plus royalties, in return for commercial rights to the antifungal drug in all markets outside the US and Japan.
Rezafungin has already been granted Orphan Drug Designation for its use in the treatment of invasive candidiasis in both the EU and US. Additionally, Cidara recently submitted a New Drug Application to the US Food and Drug Administration (FDA) for the treatment of candidemia and invasive candidiasis in the US.