FDA受理Rezzayo预防侵袭性真菌病补充申请 授予优先审评
CorMedix Therapeutics（纳斯达克代码：CRMD）10月19日宣布，美国食品药品管理局（FDA）已受理其药物REZZAYO（rezafungin，注射用）的补充新药申请，并授予优先审评。该申请寻求新增适应证：预防侵袭性真菌病，由公司的全球开发合作伙伴Mundipharma提交。FDA依据《处方药申报者付费法案》（PDUFA）给出的目标行动日期为2027年第一季度。申请依据III期ReSPECT研究结果：该研究在接受异基因造血干细胞移植的成人患者中，比较每周一次使用rezafungin与标准抗真菌方案的预防效果，今年4月公布积极顶线结果。侵袭性真菌病是造血干细胞移植等免疫受损患者的严重并发症之一。公司董事长兼首席执行官Joseph Todisco表示，若新适应证获批，公司计划于2027年下半年启动推广工作。
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.
发布：GSM·美国（发布链接）
图片来源：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
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