• The approval is based on the positive results of the pivotal Phase III ReSTORE clinical trial and is supported by STRIVE's Phase II clinical trials and an extensive non-clinical development program.^1,2
• Rezafungin is the first new treatment option for patients with invasive candidiasis in over 15 years.³

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 the results of the pivotal Phase III ReSTORE clinical trial, which demonstrated statistical non-inferiority* of once-weekly rezafungin compared to the current once-daily standard of care caspofungin.^1,2,4 These results are supported by positive results from the Phase II STRIVE clinical trial and an extensive non-clinical development program.^1,2

Invasive candidiasis is a severe, life-threatening infection of the bloodstream and/or deep/visceral tissue.^5,6 It affects seriously ill people, especially those with a weakened immune system, and the mortality rate can be 40% or more.^7,8 It can put a huge strain on the healthcare system, with the potential for extended treatment and long hospital stays.⁹ There have been no new treatments in the last 15 years and morbidity and mortality rates have remained largely the same, indicating the need for alternative treatment options.^3,10

Professor Oliver Cornely, Head of the European Centre of Excellence for Medical Mycology at the University Hospital of Cologne and a member of the Data Review Committee of the Phase III ReSTORE study, said: "There is a significant unmet need for the treatment of people with invasive candidiasis worldwide. Today's announcement by the European Commission marks an important moment that could allow the medical community to treat invasive candidiasis patients differently with a new treatment option."

"The European approval is the culmination of years of development of an additional treatment option for patients with invasive candidiasis and underscores our commitment to supporting the treatment of infectious diseases," said Yuri Martina, Chief Development and Medical Officer at Mundipharma.

Rezafungin has been granted orphan drug designation in the EU for the treatment of invasive candidiasis.¹¹

*To reach the predefined limit of non-inferiority, the upper (for all-cause mortality) and lower (for global cure) 95% confidence limits for the difference between the arms must be within 20%. Both outcomes reached the specified 20% threshold and thus demonstrated non-inferiority.¹