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Mundipharma announced today that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for rezafungin for the treatment of invasive candidiasis in adult patients. The filing 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 standard of care caspofungin, which is once-daily administered. This study provides evidence of the efficacy and safety of rezafungin as a potential first-line treatment for candidaemia and invasive candidiasis.1
Invasive candidiasis is severe, life-threatening systemic candida infection of the bloodstream and/or deep/visceral tissues.2 Despite the currently available treatments, the mortality rate in patients with invasive candidiasis remains high, up to 40%.3 There is an urgent need for new treatment options for this serious disease, especially as there have been no significant advances in treatment over the past decade.
“Rezafungin, a next-generation echinocandin, represents the first advance in the treatment of invasive Candida infections in a long time. If approved, the drug could bring new hope to critically ill, vulnerable patients battling this deadly disease in the EU,” said Brian Sheehan, Ph.D., Chief Scientific Officer at Mundipharma. “We welcome the acceptance by the EMA of our submission for rezafungin and look forward to working with the EMA to bring this medicine to patients.”
Rezafungin has already received orphan drug designation in both the EU and the US for the treatment of invasive candidiasis.4.5 A new drug application for the treatment of candidemia and invasive candidiasis in the United States was recently submitted to the US Food and Drug Administration (FDA). The FDA previously designated rezafungin as a Qualified Infectious Disease Product (QIDP), receiving both Fast Track and Priority Review designations.
Cidara has partnered with Mundipharma, which owns the commercial rights to rezafungin outside the US and Japan.
About invasive candidiasis
Invasive candidiasis (IC) continues to be an area with significant unmet needs, particularly for critically ill patients in hospital settings and those with compromised immune systems. Despite the available treatments, the mortality rate is as high as 40%.3 IC is a serious, life-threatening systematic Candida – Infection of the bloodstream and/or deep/visceral tissues known as candidemia and deep tissue candidiasis.2
About Rezafungin
Rezafungin is a novel once-weekly echinocandin developed for both the treatment and prevention of serious fungal infections such as candidemia and invasive candidiasis. Rezafungin’s structure and properties are specifically designed to enhance a clinically validated mechanism to increase efficacy and safety potential for patients. Cidara has completed a phase 3 clinical trial of rezafungin for the first-line treatment of candidaemia and/or invasive candidiasis (ReSTORE trial).6
In this ReSTORE study, rezafungin met the primary endpoint for Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) of “Global Cure” at day 14, and also the primary endpoint for Marketing Authorization Application (NDA) at the US Food and Drug Administration (FDA), all-cause mortality at 30. Both results demonstrate the statistical non-inferiority of once-weekly rezafungin to once-daily caspofungin, the current standard of care. Rezafungin was generally well tolerated and had a similar safety profile to caspofungin.6
In addition, Cidara is conducting a second phase 3 clinical trial of rezafungin for the prevention of invasive fungal diseases in patients receiving allogeneic blood and bone marrow transplants (ReSPECT trial).
About Mundipharma
Mundipharma is a global healthcare company with presence in Africa, Asia Pacific, Canada, Europe, Latin America and the Middle East.
Mundipharma is dedicated to providing patients with innovative treatments in the areas of pain management, infectious diseases, consumer health and other serious and disabling diseases. Our core values, which are based on integrity and patient orientation, determine our actions in all areas. For more information, visit www.mundipharma.com.
SciA-RZF-2200053
Date of creation: August 2022
Credits
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 accessed June 2022.
3 Kullberg BJ, Arendrup MC. Invasive Candidiasis. N Engl J Med 2015;373:1445-1456.
4 US Food & Drug Administration. Search 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 accessed: July 2022.
6 Cidara Therapeutics and Mundipharma Announce Positive Topline Results from the Global Phase 3 Pivotal ReSTORE 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-Candidemia-and/or-Invasive-Candidiasis-Demonstrating-its-Positive-Efficacy-and-Safety-Profile
The source language in which the original text is published is the official and authorized version. Translations will be included for a better understanding. Only the language version that was originally published is legally valid. Therefore, compare translations with the original language version of the publication.
View original version on businesswire.com: https://www.businesswire.com/news/home/20220817005378/en/
MEDIA CONTACT
Jan Milton-Edwards
Mundipharma
+44-7341-739-984
Tara Lanigan
Mundipharma
+44-7918-970301
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European Medicines Agency accepts marketing authorization application for rezafungin for the treatment of invasive candidiasis
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