{"id":47507,"date":"2022-08-22T10:01:43","date_gmt":"2022-08-22T08:01:43","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/european-medicines-agency-accepts-rezafungin-marketing-authorisation-application-for-the-treatment-of-invasive-candidiasis\/"},"modified":"2022-08-22T10:01:43","modified_gmt":"2022-08-22T08:01:43","slug":"european-medicines-agency-accepts-rezafungin-marketing-authorisation-application-for-the-treatment-of-invasive-candidiasis","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/european-medicines-agency-accepts-rezafungin-marketing-authorisation-application-for-the-treatment-of-invasive-candidiasis\/","title":{"rendered":"European Medicines Agency Accepts Rezafungin Marketing Authorisation Application for the Treatment of Invasive Candidiasis"},"content":{"rendered":"<div>\n<ul class=\"bwlistdisc\">\n<li>\nRezafungin is a next-generation, once-weekly echinocandin being developed for both the treatment and prevention of serious fungal infections, such as invasive candidiasis and candidemia\n<\/li>\n<li>\nThe European Medicines Agency (EMA) filing is supported by the pivotal ReSTORE Phase III clinical trial results, where rezafungin demonstrated non-inferiority to the current standard of care, caspofungin in the treatment of candidemia and\/or invasive candidiasis<sup>1<\/sup>\n<\/li>\n<\/ul>\n<ul class=\"bwlistdisc\">\n<li>\nIf approved by the EMA, rezafungin could be the first new treatment option in Europe (EU) for patients with candidemia or invasive candidiasis for over 10 years\n<\/li>\n<\/ul>\n<p>CAMBRIDGE, England&#8211;(BUSINESS WIRE)&#8211;For Trade and Medical Media Only\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20220817005377\/en\/1546731\/5\/Mundipharma_Logo_colour.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20220817005377\/en\/1546731\/21\/Mundipharma_Logo_colour.jpg\"><\/a><\/p>\n<p>\nMundipharma today announced that the European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) for rezafungin for the treatment of invasive candidiasis in adult patients. The MAA 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 safety of rezafungin as potential first-line treatment for candidemia and invasive candidiasis.<sup>1<\/sup>\n<\/p>\n<p>\nInvasive candidiasis is a severe, life-threatening systemic Candida infection of the bloodstream and\/or deep\/visceral tissues.<sup>2<\/sup> Despite currently available treatments, the mortality rate for patients with invasive candidiasis remains high at up to 40%.<sup>3<\/sup> There is a real need for new treatment options to address this serious disease, especially as there has been no significant progress in treatment over the last decade.\n<\/p>\n<p>\n\u201c<!-- no quote -->Rezafungin, as a next generation echinocandin, represents the first advancement in the treatment of invasive Candida infections in a very long time. If approved, the treatment could bring new hope for critically ill, vulnerable patients battling with this deadly disease in the EU,\u201c said Brian Sheehan, Ph.D., Chief Scientific Officer at Mundipharma. \u201cWe are pleased that the EMA has accepted our marketing authorisation application for rezafungin, and we look forward to working with the EMA to bring this medicine to patients.\u201d\n<\/p>\n<p>\nRezafungin has already been granted Orphan Drug Designation for its use in the treatment of invasive candidiasis in both the EU and US.<sup>4,5 <\/sup>A New Drug Application was recently submitted to the US Food and Drug Administration (FDA) for the treatment of candidemia and invasive candidiasis the USA. The FDA has previously identified rezafungin as a Qualified Infectious Disease Product (QIDP), which grants both Fast Track and Priority Review status.\n<\/p>\n<p>\nCidara has partnered with Mundipharma, which has commercial rights to rezafungin outside the U.S. and Japan.\n<\/p>\n<p>\n<b>About Invasive Candidiasis<\/b>\n<\/p>\n<p>\nInvasive candidiasis (IC) continues to be an area of significant unmet need, especially 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%.<sup>3<\/sup> IC is characterised as a severe, life-threatening systemic <i>Candida <\/i>infection of the bloodstream and\/or deep\/visceral tissues, known as candidemia and deep-seated tissue candidiasis.<sup>2<\/sup>\n<\/p>\n<p>\n<b>About Rezafungin<\/b>\n<\/p>\n<p>\nRezafungin is a next-generation, once-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 improve upon a clinically validated mechanism intended to enhance its efficacy and safety potential 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).<sup>6<\/sup>\n<\/p>\n<p>\nIn 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, 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.<sup>6<\/sup>\n<\/p>\n<p>\nCidara 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).\n<\/p>\n<p>\n<b>About Mundipharma<\/b>\n<\/p>\n<p>\nMundipharma is a global healthcare company with a presence across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East.\n<\/p>\n<p>\nMundipharma 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 <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.mundipharma.com&amp;esheet=52816660&amp;newsitemid=20220817005377&amp;lan=en-US&amp;anchor=www.mundipharma.com&amp;index=1&amp;md5=8bb439fcc2b25bfcc923ffb6a7d2def9\" rel=\"nofollow noopener\" shape=\"rect\">www.mundipharma.com<\/a>.\n<\/p>\n<p>\nSciA-RZF-2200053<br \/>\n<br \/>Date of preparation: August 2022\n<\/p>\n<p>\n<b>References<\/b>\n<\/p>\n<p>\n<sup>1<\/sup> 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<br \/>\n<br \/><sup>2<\/sup> Cortes JA, Corrales IF. Invasive Candidiasis: Epidemiology and Risk Factors. November 2018. Available at <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.intechopen.com%2Fchapters%2F64365.%2520Last%2520accessed%2520June%25202022&amp;esheet=52816660&amp;newsitemid=20220817005377&amp;lan=en-US&amp;anchor=https%3A%2F%2Fwww.intechopen.com%2Fchapters%2F64365.+Last+accessed+June+2022&amp;index=2&amp;md5=f26a6fc66b2707a88a595e9d16c6412c\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/www.intechopen.com\/chapters\/64365. Last accessed June 2022<\/a>.<br \/>\n<br \/><sup>3<\/sup> Kullberg BJ, Arendrup MC. Invasive Candidiasis. N Engl J Med 2015;373:1445-1456.<br \/>\n<br \/><sup>4<\/sup> U.S. Food &amp; Drug Administration. Search Orphan Drug Designations and Approvals. Available at: <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.accessdata.fda.gov%2Fscripts%2Fopdlisting%2Foopd%2FdetailedIndex.cfm%3Fcfgridkey%3D%2520507215&amp;esheet=52816660&amp;newsitemid=20220817005377&amp;lan=en-US&amp;anchor=https%3A%2F%2Fwww.accessdata.fda.gov%2Fscripts%2Fopdlisting%2Foopd%2FdetailedIndex.cfm%3Fcfgridkey%3D%2520507215&amp;index=3&amp;md5=42bb157fd8bd6b885310774701b11c84\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/www.accessdata.fda.gov\/scripts\/opdlisting\/oopd\/detailedIndex.cfm?cfgridkey=%20507215<\/a> . Last accessed July 2022<br \/>\n<br \/><sup>5<\/sup> European Commission. Community Register of orphan medicinal products. Available at: <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fec.europa.eu%2Fhealth%2Fdocuments%2Fcommunity-register%2Fhtml%2Fo2385.htm&amp;esheet=52816660&amp;newsitemid=20220817005377&amp;lan=en-US&amp;anchor=https%3A%2F%2Fec.europa.eu%2Fhealth%2Fdocuments%2Fcommunity-register%2Fhtml%2Fo2385.htm&amp;index=4&amp;md5=cf02b060ff8a39022c0e8cc30ab32c81\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/ec.europa.eu\/health\/documents\/community-register\/html\/o2385.htm<\/a>. Last accessed July 2022.<br \/>\n<br \/><sup>6<\/sup> 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 <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.mundipharma.com%2FMundipharma-and-Cidara-Therapeutics-Announce-First-Presentation-of-Results-from-Global-Phase-3-ReSTORE-Trial-of-Rezafungin-for-Treatment-of-Candidemia-and%2For-Invasive-Candidiasis-Demonstrating-its-Positive-Efficacy-and-Safety-Profile&amp;esheet=52816660&amp;newsitemid=20220817005377&amp;lan=en-US&amp;anchor=https%3A%2F%2Fwww.mundipharma.com%2FMundipharma-and-Cidara-Therapeutics-Announce-First-Presentation-of-Results-from-Global-Phase-3-ReSTORE-Trial-of-Rezafungin-for-Treatment-of-Candidemia-and%2For-Invasive-Candidiasis-Demonstrating-its-Positive-Efficacy-and-Safety-Profile&amp;index=5&amp;md5=d23a75679e9a7975f043a366cb3f427c\" rel=\"nofollow noopener\" shape=\"rect\">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<\/a>\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\n<b>MEDIA CONTACT<\/b><br \/>Jan Milton-Edwards<br \/>\n<br \/>Mundipharma<br \/>\n<br \/>+44-7341-739-984<br \/>\n<br \/><a target=\"_blank\" href=\"&#109;&#x61;&#105;&#x6c;&#116;&#x6f;:&#x6a;a&#x6e;&#46;&#109;&#x69;&#108;&#x74;&#111;&#x6e;&#45;&#x65;d&#x77;a&#x72;d&#115;&#x40;&#109;&#x75;&#110;&#x64;&#105;&#x70;h&#x61;r&#x6d;a&#46;&#x63;&#111;&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">&#106;&#97;&#x6e;&#x2e;&#109;&#105;&#x6c;&#x74;&#111;&#110;&#x2d;&#x65;&#100;&#119;&#x61;&#x72;&#100;&#115;&#x40;&#x6d;&#117;&#110;&#x64;&#x69;&#112;&#104;&#x61;&#x72;&#109;&#97;&#x2e;&#x63;&#111;&#109;<\/a>\n<\/p>\n<p>\nTara Lanigan<br \/>\n<br \/>Mundipharma<br \/>\n<br \/>+44-7918-970301<br \/>\n<br \/><a target=\"_blank\" href=\"&#109;&#x61;&#105;&#x6c;&#116;&#x6f;&#58;&#x74;a&#x72;a&#x2e;l&#x61;n&#105;&#x67;&#97;&#x6e;&#64;&#x6d;&#117;&#x6e;&#100;&#x69;p&#x68;a&#x72;m&#x61;&#46;&#99;&#x6f;&#109;\" rel=\"nofollow noopener\" shape=\"rect\">&#x74;&#x61;&#x72;&#x61;&#x2e;&#x6c;&#97;&#110;&#105;&#103;an&#64;m&#x75;&#x6e;&#x64;&#x69;&#x70;&#x68;&#97;&#114;&#109;&#97;&#46;com<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Rezafungin is a next-generation, once-weekly echinocandin being developed for both the treatment and prevention of serious fungal infections, such as invasive candidiasis and candidemia The European Medicines Agency (EMA) filing is supported by the pivotal ReSTORE Phase III clinical trial results, where rezafungin demonstrated non-inferiority to the current standard of care, caspofungin in the treatment &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/european-medicines-agency-accepts-rezafungin-marketing-authorisation-application-for-the-treatment-of-invasive-candidiasis\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-47507","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>European Medicines Agency Accepts Rezafungin Marketing Authorisation Application for the Treatment of Invasive Candidiasis - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/european-medicines-agency-accepts-rezafungin-marketing-authorisation-application-for-the-treatment-of-invasive-candidiasis\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"European Medicines Agency Accepts Rezafungin Marketing Authorisation Application for the Treatment of Invasive Candidiasis - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"Rezafungin is a next-generation, once-weekly echinocandin being developed for both the treatment and prevention of serious fungal infections, such as invasive candidiasis and candidemia The European Medicines Agency (EMA) filing is supported by the pivotal ReSTORE Phase III clinical trial results, where rezafungin demonstrated non-inferiority to the current standard of care, caspofungin in the treatment ... 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