CAMBRIDGE, United Kingdom –
For trade and medical media only
Mundipharma today announced 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 showed statistical non-inferiority of once-weekly rezafungin compared to the current standard-of-care caspofungin, administered once daily. This study provides evidence of the efficacy and safety of rezafungin as a potential first-line treatment for candidemia and invasive candidiasis.1
Invasive candidiasis is serious, life-threatening systemic candida infection of the bloodstream and/or deep/visceral tissues.2 Despite currently available treatments, the mortality rate in patients with invasive candidiasis remains high, up to 40%.3 There is an urgent need for new treatments for this serious disease, especially since there has been no significant progress 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 facing this deadly disease in the EU is struggling,” said Brian Sheehan, Ph.D., Chief Scientific Officer at Mundipharma. “We welcome the EMA’s acceptance 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 of significant unmet need, 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 systemic Candida – Infection of the bloodstream and/or deep/visceral tissues known as candidemia and deep tissue candidiasis.2
Rezafungin is a new 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 with rezafungin for the first-line treatment of candidemia 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” on day 14, and also the primary endpoint for Marketing Authorization Application (NDA) to the US Food and Drug Administration Administration (FDA), all-cause mortality at 30. Both results demonstrate the statistical noninferiority of once-weekly rezafungin versus 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).
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.
Date of creation: 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. Presenter Abstract 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 visited June 2022.
3 Kullberg BJ, Arendrup MC. Invasive candidiasis. N Engl J Med 2015;373:1445-1456.
4 US Food and Drug Administration. Search for orphan drug designations and approvals. Available at: https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=%20507215. Last visited: July 2022
5 European Commission. Community register of orphan drugs. Available at: https://ec.europa.eu/health/documents/community-register/html/o2385.htm. Last visited: July 2022.
6 Cidara Therapeutics and Mundipharma announce positive top-line results from the global Phase 3 pivotal RESTORE trial of Rezafungin for the treatment of Candidemia and Invasive Candidiasis. Available unter 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-Demonstrates-its-positive-efficacy-and-safety-profile
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Source: Business Wire