CAMBRIDGE, England--(BUSINESS WIRE)--Napp today announces that the MHRA has accepted a marketing authorisation application for rezafungin, a novel echinocandin in clinical development for the treatment of invasive candidiasis in adult patients. The marketing authorisation application is based on results from the pivotal ReSTORE Phase III clinical trial, which demonstrated statistical non-inferiority of rezafungin dosed once-weekly when compared to the current standard of care, caspofungin, dosed once daily. This trial provides evidence of efficacy and the safety profile of rezafungin as a potential treatment for candidemia and invasive candidiasis with a once-weekly dosing schedule.1 Invasive candidiasis is a severe, life-threatening systemic Candida infection of the bloodstream and/or deep/visceral tissues.2 Despite current treatments, the mortality rate for patients with invasive candidiasis remains high at up to 40%.3 Antifungal drug resistance is becoming an increasing concern, with 90% of Candida auris strains showing resistance to fluconazole, one of the major treatment options. Echinocandin resistance is currently uncommon (5–10%).4 There is a real need for new treatment options to address this serious disease, especially as there has been no significant additional treatment options over the last decade. In the ReSTORE trial, rezafungin met the primary endpoint for the European Medicines Agency (EMA) marketing authorisation application of global cure at Day 14. The MHRA has agreed they will accept the EMA primary endpoint. “If approved, rezafungin, as a novel, once-weekly echinocandin, could bring new hope for critically ill, vulnerable patients battling with this difficult-to-treat and often deadly disease,“ said Brian Sheehan, Ph.D., Chief Scientific Officer at Mundipharma. “With the rise in multidrug-resistant Candida strains in hospitals, this MHRA marketing authorisation submission is a positive step, and we hope we will be able to work with the MHRA to bring this medicine to patients who need it.” In this ReSTORE trial, rezafungin met the primary endpoint for the European Medicines Agency (EMA) Marketing Authorization Application (MAA) submission of global cure at Day 14, which the MHRA has agreed to accept, and also met the primary endpoint for the U.S. Food and Drug Administration (FDA) New Drug Application (NDA) submission of all-cause mortality at Day 30. Both of these results demonstrated statistical non-inferiority of rezafungin dosed once-weekly, versus caspofungin dosed once-daily, which is the current standard of care. Rezafungin was generally well tolerated and had a similar safety profile to caspofungin.9 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 marrow transplantation (ReSPECT trial). Napp is part of the global network of Mundipharma independent associated companies, which has a presence across 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 Healthcare as well as other severe and debilitating disease areas. Our guiding principles, centered around Integrity and Patient-Centricity, are at the heart of everything we do. For more information visit www.mundipharma.com. Registered office addresses
1 Thompson, G.R. 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 October 2022. 4 Cortegiani A et al. Crit Care. 2019;23(1):150.
5 U.S. 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 October 2022.
6 European Commission. Community Register of orphan medicinal products. Available at: https://ec.europa.eu/health/documents/community-register/html/o2385.htm. Last accessed October 2022.
7 U.S. Food & Drug Administration. Search Orphan Drug Designations and Approvals. Available at: https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey= 507215. Last accessed October 2022.
8 Cidara Therapeutics Press Releases. Available at: https://www.cidara.com/news/cidara-therapeutics-announces-fda-acceptance-for-priority-review-of-new-drug-application-for-rezafungin-for-the-treatment-of-candidemia-and-invasive-candidiasis/. Last accessed October 2022.
9 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.Last accessed October 2022. Date of preparation: November 2022