6 hours Ago By Editorial Staff
The marketing authorisation was based on results from the pivotal ReSTORE Phase III clinical trial Mundipharma has announced that rezafungin is now available in the Republic of Ireland for adult patients with invasive candidiasis following HSE’s reimbursement agreement. 1 The authorisation is supported by 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. The primary efficacy outcome was global response (confirmed by the Data Review Committee [DRC]) at day 14.
Global response was determined from clinical response, mycological response, and radiologic response (for qualifying subjects with invasive candidiasis). Of the 187 patients in the modified intention-to-treat (mITT) population, 59.1% of patients in the rezafungin group (55/93) and 60.
6% of patients in the caspofungin group (57/94) had a global response of cure at day 14 (weighted treatment difference −1.1% [95% CI −14.9, 12.
7]. 3 These findings are supported by the STRIVE Phase II clinical trial and an extensive non-clinical development programme. 3,4 Rezafungin was generally well tolerated, very common adverse reactions include hypokalaemia, pyrexia, and diarrhoea.
2 Invasive candidiasis, is a severe, life-threatening infection of the bloodstream and/or deep/visceral tissues. 10,11 It usually affects seriously ill people and those with a weakened immune system, the mortality rate can be 40% or more. 12-14 It can place a large burden on the healthcare system, with the potential for extended treatment regimens and long hospital stays.
15 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. 5-9,16 Job code: IE-RZF-2500043 Date of preparation: April 2025 A new global guideline for the diagnosis and treatment of Candida infections was published in Lancet Infectious Diseases in February 2025. The guideline sets out new standards for managing fungal infections, which affect millions of people worldwide every year, and include the use of all echinocandins including rezafungin.
17 Professor Ignacio Martin-Loeches , Consultant in Intensive Care Medicine at St. James’s Hospital, Professor of Intensive Care Medicine at Trinity College Dublin, and internationally renowned researcher with an H-index of 98 and nearly 40,000 citations across more than 600 peer-reviewed publications, said: “Invasive candidiasis continues to be one of the most serious infectious threats in critical care, associated with alarmingly high mortality rates despite the availability of current antifungal therapies. It primarily affects the most vulnerable patients—those who are critically ill or immunocompromised—and remains difficult to treat effectively.
Over the past 15 years, there have been few therapeutic advances, leaving clinicians with limited options in the face of this life-threatening infection. This reality underscores the urgent need for new antifungal agents. Invasive fungal infections consistently rank among the highest contributors to sepsis-related mortality, yet they receive disproportionately less attention in the development pipeline.
To reverse this trend, we need meaningful collaboration between academia, clinical practice, and the pharmaceutical industry, backed by sustained investment in antimicrobial innovation. Only through such coordinated efforts can we bring forward the next generation of antifungal treatments, that will strengthen our ability to manage severe infections in the most fragile populations.” “Making rezafungin available in the Republic of Ireland 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 Dr Yuri Martina , Chief Development and Medical Officer at Mundipharma.
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