CAMBRIDGE, England–(BUSINESS WIRE)–For business and medical media only
Mundipharma announced today that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MA) for rezafungin for the treatment of invasive candidiasis in adult patients. The marketing authorization is based on the results of the pivotal phase III ReSTORE clinical trial, which demonstrated statistical non-inferiority of rezafungin administered once a week compared to the current standard treatment, caspofungin, administered once a day . This trial provides evidence for the efficacy and safety of rezafungin as a potential first-line treatment for candidemia and invasive candidiasis.1
Invasive candidiasis is a severe and life-threatening systemic Candida infection of the bloodstream and/or deep/visceral tissues.2 Despite currently available treatments, the mortality rate of patients with invasive candidiasis remains high at up to 40%.3 There is a real need for new treatment options to treat this serious disease, especially since there have been no significant advances in treatment over the past decade.
“Rezafungin, as a next-generation echinocandin, represents the first breakthrough in the treatment of invasive Candida infections in a very long time. If approved, the treatment could bring new hope to critically ill and vulnerable patients battling this deadly disease in the EU,” said Brian Sheehan, Ph.D., Chief Scientific Officer of Mundipharma. “We are delighted that the EMA has accepted our marketing authorization 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 the US.4.5 A New Drug Application was recently submitted to the United States Food and Drug Administration (FDA) for the treatment of candidemia and invasive candidiasis in the United States. The FDA 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 owns the commercial rights to rezafungin outside of the United States and Japan.
About Invasive Candidiasis
Invasive candidiasis (IC) continues to be an area of significant unmet need, particularly for critically ill patients in hospitals and patients with compromised immune systems. Despite a number of available treatments, the mortality rate for patients with invasive candidiasis is as high as 40%.3 IC is characterized by severe, life-threatening systemic involvement. candidiasis infection of the bloodstream and/or deep/visceral tissues, called candidemia and deep tissue candidiasis.2
Rezafungin is a next-generation weekly echinocandin developed 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 enhance a clinically validated mechanism intended to enhance its efficacy and potential safety for patients. Cidara has completed a Phase III clinical trial with rezafungin for the first-line treatment of candidemia and/or invasive candidiasis (ReSTORE trial).6
In this ReSTORE trial, rezafungin met the primary endpoint for European Medicines Agency (EMA) Marketing Authorization Application (MAA) submission of overall cure at day 14, and also met the U.S. Food and Drug Administration (FDA) primary review criterion for new drug. Submission (NDA) of all-cause mortality at day 30. These two results demonstrated the statistical non-inferiority of rezafungin administered once weekly, compared to caspofungin administered once daily, which is the standard of care current. Rezafungin was generally well tolerated and had a similar safety profile to caspofungin.6
Cidara is also currently conducting a second Phase III clinical trial of rezafungin for the prevention of invasive fungal disease in patients undergoing allogeneic blood and bone marrow transplantation (ReSPECT trial).
Mundipharma is a global healthcare company with operations in Africa, Asia-Pacific, Canada, Europe, Latin America and the Middle East.
Mundipharma is dedicated to bringing innovative treatments to patients in the areas of pain management, infectious disease and consumer health, as well as other serious and debilitating disease areas. Our guiding principles, centered on integrity and patient orientation, are at the heart of everything we do. For more information, visit www.mundipharma.com.
Date of preparation: August 2022
1 Thompson, GR et al, ReSTORE: Efficacy and Safety Results of the Phase 3, Noninferiority Trial of Rezafungin in the Treatment of Candidemia and/or Invasive Candidiasis, Abstract presented at ECCMID 2022
2 Cortes JA, Corrales IF. Invasive candidiasis: epidemiology and risk factors. November 2018. Available at https://www.intechopen.com/chapters/64365. Last consulted in June 2022.
3 Kullberg BJ, Arendrup MC. Invasive candidiasis. N Engl J Med 2015;373:1445-1456.
4 US Food and Drug Administration. Look for orphan drug designations and approvals. Available at: https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=%20507215. Last accessed July 2022
5 European Commission. Community Register of Orphan Medicinal Products. Available at: https://ec.europa.eu/health/documents/community-register/html/o2385.htm. Last consulted in July 2022.
6 Cidara Therapeutics and Mundipharma announce positive top results from the pivotal Phase 3 ReSTORE global trial of rezafungin for the treatment of candidemia and invasive candidiasis. Available at https://www.mundipharma.com/Mundipharma-and-Cidara-Therapeutics-Announce-First-Presentation-of-Results-from-Global-Phase-3-ReSTORE-Trial-of-Rezafungin-for-Treatment- of-candidaemia-and/or-invasive-candidiasis-demonstrating-its-positive-efficacy-and-its-safety-profile
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