FDA Accepts Rezzayo Supplemental NDA for Invasive Fungal Disease Prevention, Grants Priority Review
CorMedix Therapeutics (Nasdaq: CRMD) announced on October 19 that the U.S. Food and Drug Administration (FDA) has accepted for filing the supplemental New Drug Application for REZZAYO (rezafungin for injection) and granted it Priority Review. The application, submitted by the company's global development partner Mundipharma, seeks approval of REZZAYO for the prophylaxis of invasive fungal disease. The FDA set a Prescription Drug User Fee Act (PDUFA) target action date in the first quarter of 2027. The filing is supported by the Phase 3 ReSPECT study, which compared once-weekly rezafungin with standard antimicrobial regimens in adults undergoing allogeneic hematopoietic stem cell transplantation and reported positive topline results in April 2026. Invasive fungal diseases are a serious complication for immunocompromised patients such as transplant recipients. Chairman and Chief Executive Officer Joseph Todisco said the company plans to begin promotion in the second half of 2027 if the new indication is approved.
Published by GSM · USA (original Chinese edition)
Photo: 美国食品药品管理局（FDA）位于马里兰州Silver Spring的White Oak园区31号楼。照片：FDA官方图片，公共领域，经维基共享资源／FDA Building 31 at the White Oak campus in Silver Spring, Maryland. Photo: U.S. Food and Drug Administration, public domain, via Wikimedia Commons
