Mundipharma has announced rezafungin (rezafungin acetate) has been approved
in the European Union (EU) for the treatment of invasive candidiasis in adults.
The approval by the European Commission (EC) follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) and is based on results from the pivotal ReSTORE Phase III clinical trial, which demonstrated statistical non-inferiority for
rezafungin, dosed once weekly, when compared to the current standard of care, caspofungin, dosed once daily. These findings are supported by the positive results of the STRIVE Phase II clinical trial and an extensive nonclinical development program.
Invasive candidiasis, is a severe, life-threatening infection of the bloodstream and/or deep/visceral tissues. It affects seriously ill people, especially those with a weakened immune system and the mortality rate can be 40% or more. It can place a large burden
on the healthcare system, with the potential for extended treatment regimens and long hospital stays. Over the last 15 years, there have been no new treatments and morbidity and mortality rates remain largely the same, indicating the need for alternative treatment
options.
Professor Oliver Cornely, Head of the European Excellence Centre for Medical Mycology at the University Hospital Cologne, Germany, and Data Review Committee member in the Phase III ReSTORE trial, said: “There has been a significant global unmet need for treating people with invasive candidiasis. Today’s announcement by the European Commission marks an important moment that could enable the healthcare professional community to manage invasive candidiasis patients in a different way using a new treatment option.”
“The European approval is a culmination of years of developing an additional treatment option for invasive candidiasis patients and underscores our commitment to supporting management of infectious diseases,” said Yuri Martina, Chief Development and Medical
Officer at Mundipharma.
Rezafungin has been granted Orphan Drug Designation for its use in the treatment of invasive candidiasis in the EU.
