CorMedix, a biopharmaceutical company dedicated to developing and commercialising therapeutic products for life-threatening diseases, has recently announced the approval of a taurolidine and heparin combination marketed as DefenCath catheter lock solution (CLS) by the U.S. Food and Drug Administration (FDA).
.The company stated that this groundbreaking solution is designed to decrease the incidence of catheter-related bloodstream infections (CRBSIs) in adult patients with kidney failure undergoing chronic hemodialysis through a central venous catheter (CVC).
According to the statement, DefenCath became the first FDA-approved antimicrobial CLS in the United States. A Phase 3 clinical study showcased its remarkable efficacy, revealing a reduction in CRBSI risk by up to 71%.
Commenting on the approval, Chief Executive Officer of CorMedix, Joseph Todisco, said, “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.”
Sharing the insights from the clinical trial, the statement added that the FDA's approval of DefenCath followed the analysis of results from the LOCK-IT-100 clinical trial, a randomised, double-blind, active control, multicenter Phase 3 study. This trial, encompassing 806 participants, showed a substantial reduction in CRBSI events among those treated with DefenCath compared to the control group, with a statistically significant 71% reduction in risk.
Pointing out that the approval will have a profound impact on patients, Edward V. Hickey, III, President of the American Association of Kidney Patients and Chair of the Veterans Health Initiative, said, “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.”
It may be noted that CRBSIs pose a significant threat, especially in patients with CVCs, with about 80% of hemodialysis patients initially requiring a CVC for vascular access. These infections can occur in up to a third of HD-CVC patients, leading to hospitalisations, extended stays, and long-term complications, including cardiovascular events.