The US Food and Drug Administration (FDA) has approved CorMedix’s DefenCath, the first and only antimicrobial catheter lock solution (CLS) in the USA to receive such an approval. DefenCath, which has been shown to reduce the risk of catheter-related bloodstream infections (CRBSIs) by up to 71% in studies, is expected to be available in inpatient settings in early 2024.
The FDA approval of DefenCath comes after results from a randomised, double-blind, active control, multicentre pivotal Phase 3 LOCK-IT-100 clinical trial, which was designed to test the efficacy and safety of the CLS for reducing the incidences of CRBSIs in patients with kidney failure receiving chronic haemodialysis. 806 participants in this study were randomised to receive either DefenCath or heparin as a CLS, with patients in the DefenCath group having a lower instance of CRBSI events compared to those 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.
Commenting on the recent FDA approval, CEO of CorMedix Joseph Todisco said “the approval of DefenCath marks a major advancement in reducing life-threatening infections for patients receiving haemodialysis 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. We thank all the patients, caregivers, clinical investigators, and our employees who have played an integral role in the development and regulatory approval of DefenCath. Our commercial team along with our broader organisation is preparing for commercial launch, and we look forward to working with healthcare providers and facilities to give haemodialysis patients access to DefenCath in early 2024.”
Edward V Hickey III, a former kidney patient and president of the American Association of Kidney Patients, added that: “Patients and their loved ones have faced many burdens related to kidney failure, including complications caused by catheter related bloodstream infections and associated loss of work, severe disability and death. Until now, patients who need haemodialysis via a central venous catheter have had little choice other than to accept high infection risks associated with the existing standard of care. The FDA’s approval of DefenCath is a meaningful moment for patients and their healthcare providers because they now have a new alternative to reduce the risks of CRBSIs.”