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Napp announces acceptance of their Rezafungin Marketing Authorisation Application for the Treatment of Invasive Candidiasis to the UK Medicines and Healthcare Products Regulatory Agency

2022-11-16

临床3期临床结果申请上市优先审批孤儿药

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 applirezafunginglobal curechinocandin The MHRA has agreed they will accept the EMA invasive candidiasis rezafungin caspofungin rezafungin candidemia invasive candidiasis

Invasive candidiasisngin, as a novel, once-weekly esystemic Candida infectionew hope for critically ill, vulnerable patients battling with this difficult-to-treat and often deadly disease,“ saiinvasive candidiasisD., Chief Scientific Officer at Mundipharma. “With the rise in multidrug-resistant Candida strains in hospitals, this MHRA marketing authorisation fluconazoleis a positive step, and we hope we wilEchinocandin work with the MHRA to bring this medicine to patients who need it.”

Rezafungin has alreadyrezafunginted Orphan Drug Designation for itEuropean Medicines Agency (EMA)ive candidiasis in both the EU and US.5,6 It has been identified as a Qualified Infectious Disease Product (QIDP) by the US Food and Drug Administration (FDA),7 which confers both Fast Track and Priority Review status and has been accepted for marketing authorisation review by the EMA. In the US, the FDA has granted Priority Review to Cidara Therapeutics New Drug Application for rezafungin for the treatment of candidemia and invasive candidiasis.8

Cidara Theraperezafunginpartnered with Mundipharmaechinocandincommercial rights to rezafungin outside the US and Japan.Mundipharma

Rezafunginsive Candidiasisinvasive candidiasis Food and Drug Administration (FDA)EMA FDA Cidara Therapeutics rezafungin candidemia invasive candidiasis.8

Cidara Therapeuticss (IC) continues to Mundipharmaof significant unmet need, especirezafunginritically 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 characterised as a severe, life-threatening systemic Candida infection of the bloodstream and/or deep/visceral tissues, known as candidemia and deep-seated tissue candidiasis.2

About Invasive Candidiasis

Invasive candidiasis (IC)ce-weekly echinocandin being 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 improinvasive candidiasis validated mechanism intended to enhance its efficacy and safety potentsystemic Candida infectionas completed a Phase III clinical trial with rezafungin forcandidemiament of candidemia and/ocandidiasis.2ndidiasis (ReSTORE trial).9

In thiRezafungintrial, 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

Rezafunginalso currently conductingechinocandinase III clinical trial of rezafungin for the prevention of invasivfungal infectionsin patientinvasive candidiasiseic bcandidemiaarrow transplantation (ReSPECT trirezafungin Cidara rezafungin candidemia invasive candidiasis

About Napprezafungin European Medicines Agency (EMA)U.S. Food and Drug Administration (FDA)rezafungin caspofungin Rezafungin caspofungin.9

Cidaras part of the global network of Mundipharma independent associated rezafungin which has a presence ainvasive fungal diseasefic, Canada, Europe, Latin America, and the Middle East.

MundipNappa 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.

Nappstered office addressesMundipharma

NAPP PHARMACEUTICALS LIMITED a company having its registered office at Cambridge SciencPainrk, Milton Road, Cambridge CB4 0AB, England.

MUNDIPHARMA RESEARCH LIMITED, a company having its registered office at Cambridge Science Park, Milton Road, Cambridge, CB4 OAB, England.

NAPP PHARMACEUTICALS

MUNDIPHARMA RESEARCH LIMITEDORE: 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.

3 Kullberg BJ, Arendrup MC. Invasive Candidiasis. N Engl J Med 2015;373:1445-1456.Rezafungin Candidemia Invasive Candidiasis

4 Cortegiani A et al. CritInvasive Candidiasis0.

5 U.S. Food & Drug AdministrInvasive Candidiasis 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.

JoCidara Therapeutics009

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