The European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) for Mundipharma’s rezafungin for the treatment of invasive candidiasis in adult patients.
The MAA is based on results from the pivotal ReSTORE Phase III clinical trial, which demonstrated statistical non-inferiority of rezafungin dosed once weekly when compared to the current standard of care, caspofungin, dosed once daily. This trial provides evidence of efficacy and safety of rezafungin as potential first-line treatment for candidemia and invasive candidiasis.
Invasive candidiasis is a severe, life-threatening systemic Candida infection of the bloodstream and/or deep/visceral tissues. Despite currently available treatments, the mortality rate for patients with invasive candidiasis remains high at up to 40%. There is a real need for new treatment options to address this serious disease, especially as there has been no significant progress in treatment over the last decade.
“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,“ said Brian Sheehan, Ph.D., chief scientific officer at Mundipharma. “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.”
Rezafungin has already been granted Orphan Drug Designation for its use in the treatment of invasive candidiasis in both the EU and US. A New Drug Application was recently submitted to the US Food and Drug Administration (FDA) for the treatment of candidemia and invasive candidiasis in the USA. The FDA has previously identified rezafungin as a Qualified Infectious Disease Product (QIDP), which grants both Fast Track and Priority Review status.
Cidara has partnered with Mundipharma, which has commercial rights to rezafungin outside the U.S. and Japan.