CorMedix Inc’s Defencath (taurolidine and heparin) catheter lock solution (CLS) has received FDA approval for the prevention and treatment of catheter-related bloodstream infections (CRBSIs) in adults with kidney failure undergoing chronic hemodialysis via central venous catheters (CVCs). This milestone marks a significant advancement in reducing life-threatening infections for a vulnerable patient population.
Defencath is a sterile, preservative-free, clear, aqueous-based solution and the first and only antimicrobial CLS approved by the FDA in the United States. The approval of Defencath not only addresses a critical unmet medical need but also represents a major achievement for CorMedix.
Joseph Todisco, CEO of CorMedix, expressed the significance of this approval, stating, “The approval of DefenCath marks a major advancement in reducing life-threatening infections for patients receiving hemodialysis via central venous catheters and an important milestone for CorMedix.” He extended gratitude to all those involved in the development and regulatory approval of DefenCath and highlighted the company’s commitment to launching the product to benefit hemodialysis patients in early 2024.
Groundbreaking Reduction in Bloodstream Infections for Hemodialysis Patients
The approval of Defencath is grounded in data from the Phase 3 LOCK-IT-100 clinical study, which was a randomized, double-blind, multicenter trial assessing the efficacy and safety of DefenCath in lowering the incidence of catheter-related bloodstream infections in patients with kidney failure undergoing chronic hemodialysis. The results revealed a remarkable 71% reduction in the risk of developing catheter-related bloodstream infections among patients using DefenCath compared to those using heparin as a CLS.
In terms of safety, the study found that adverse events (AEs) in the DefenCath group were similar to those in the control cohort. Notably, there was a low incidence of heparin-induced thrombocytopenia (HIT), a condition that can lead to life-threatening clotting in veins and arteries. In cases of HIT, the FDA advises discontinuing treatment with Defencath and initiating a different medication.
Hypersensitivity reactions were also reported in a small percentage of patients in the study, warranting the discontinuation of Defencath use. Other potential AEs included hemodialysis catheter malfunction, hemorrhage/bleeding, nausea, vomiting, dizziness, and musculoskeletal chest pain.
Vital Solution in CRBSI Prevention for Hemodialysis Patients
Patients with kidney failure often require hemodialysis, which involves filtering waste and excess water from the blood. This process typically necessitates the use of catheters, increasing the risk of catheter-related bloodstream infections. Until now, patients undergoing hemodialysis with CVCs have had limited options to reduce CRBSI risk, making the FDA’s approval of DefenCath a significant milestone for both patients and healthcare providers.
Edward V. Hickey, III, president of the American Association of Kidney Patients and Chair of the Veterans Health Initiative, emphasized the importance of this approval for patients and their healthcare providers, offering a new alternative to mitigate CRBSI risks. He noted that patients with kidney failure face numerous challenges, including complications from CRBSIs, and that the approval of DefenCath addresses a critical need in their care.
Resource: PharmExec, November 15, 2023

This article has been prepared with the assistance of AI and reviewed by an editor. For more details, please refer to our Terms and Conditions. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author.