CorMedix Announces FDA Acceptance for Filing & Priority Review of NDA

CorMedix Inc. recently announced the US FDA has accepted for filing the company’s submitted New Drug Application (NDA) for Defencath, its product candidate to be used as a catheter lock solution in hemodialysis patients for the prevention of catheter related blood stream infections (CRBSI). The FDA had previously granted a rolling submission and review, which the company completed at the end of June.  The FDA also granted priority review and set a Prescription Drug User Fee Act (PDUFA) date of February 28, 2021, for the completion of its review for approval of the NDA.  The agency noted that it is planning to hold an advisory committee meeting to discuss the application and that it had not identified any potential review issues at this time.

Khoso Baluch, CorMedix CEO, said “The NDA acceptance is truly a momentous achievement for CorMedix, the internal and external teams involved with the submission, and most importantly, the hemodialysis patient community. We are proud of our team for  exceptional effort to get us to this point and look forward to bringing Defencath to patients to prevent the serious complications and costs associated with CRBSI in this significant patient population.”

Phoebe Mounts, CorMedix Executive Vice President and General Counsel, added “Having been actively involved with the Defencath program and regulatory journey for the past several years, it is very rewarding to have the FDA’s acceptance of our first NDA as an essential step toward our goal of offering Defencath in the US as the first antimicrobial catheter lock solution for the prevention of life-threatening CRBSI in hemodialysis patients. We are very appreciative that the agency granted priority review and despite the ongoing pandemic, we look forward to continuing to work together expeditiously to complete the review of the Defencath NDA to address an unmet medical need.”

The FDA grants priority review to applications for potential therapies that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions when compared to standard applications. CorMedix included in the Defencath NDA submission positive results from the 795 patient LOCK-IT-100 clinical trial, which demonstrated a good safety profile and a highly statistically significant reduction of 71% (p=0.0006) in CRBSI in patients undergoing hemodialysis compared to heparin, the current standard of care. Defencath had been granted Fast Track and Qualified Infectious Disease Product (QIDP) designations by the FDA, which provided eligibility to request priority review of the NDA.

CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases. The company is focused on developing its lead product Defencath, a novel, antibacterial and antifungal solution designed to prevent costly and life-threatening bloodstream infections associated with the use of central venous catheters in patients undergoing chronic hemodialysis. Defencath has been designated by FDA as Fast Track and as a Qualified Infectious Disease Product, which provides an additional 5 years of marketing exclusivity, which will be added to the five years granted to a New Chemical Entity upon approval of the NDA. CorMedix also intends to develop Defencath as a catheter lock solution for use in oncology and total parenteral nutrition patients. It is leveraging its taurolidine technology to develop a pipeline of antimicrobial medical devices, with programs in surgical sutures and meshes, and topical hydrogels.  The company is also working with top-tier researchers to develop taurolidine-based therapies for rare pediatric cancers.  Neutrolin is CE Marked and marketed in Europe and other territories as a medical device.  For more information, visit www.cormedix.com.