FDA approval for DefenCath (taurolidine and heparin) catheter lock solution to reduce the incidence of catheter-related bloodstream infections – CorMedix

CorMedix Inc. announced that the FDA has approved DefenCath (taurolidine and heparin) catheter lock solution (CLS) to reduce the incidence of catheter-related bloodstream infections (CRBSIs) for the limited population of adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter (CVC). DefenCath is the first and only FDA-approved antimicrobial CLS in the U.S. and was shown to reduce the risk of CRBSIs by up to 71% in a Phase III clinical study.

Joseph Todisco, Chief Executive Officer of CorMedix commented, “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. As the first FDA-approved antimicrobial catheter lock solution designed to prevent CRBSIs, DefenCath offers healthcare providers an option to reduce the risk of infections in a patient population already vulnerable due to underlying kidney failure.”

The FDA approval of DefenCath was supported by results from the randomized, double-blind, active control, multicenter pivotal Phase III LOCK-IT-100 clinical trial designed to assess the efficacy and safety of DefenCath for reducing the incidence of CRBSIs in patients with kidney failure receiving chronic hemodialysis. In the study, a total of 806 subjects were randomized to receive either DefenCath or heparin as a CLS. Patients in the DefenCath group had a lower incidence of CRBSI events compared to patients in the control group. The Hazard Ratio was 0.29, corresponding to a statistically significant 71% reduction in risk of developing a CRBSI. An independent Data Safety and Monitoring Board recommended an early termination of the study based on demonstrated efficacy and a pre-specified level of statistical significance with no safety concerns. Adverse events were comparable to control.