CorMedix Inc. announced that the U.S. Food and Drug Administration (FDA) has approved DefenCath(R) (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 3 clinical study. The FDA approval of DefenCath was supported by results from the randomized, double-blind, active control, multicenter pivotal Phase 3 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 through a central Venous catheter.

The FDA approval of DefENCath was supported by results from The randomized, double-blind, Active control, multicenter pivotal Phase3 LOCK-IT-100clinical trial designed to assess the efficacy, safety of DefenCath for reduce the incidence of CRBSIs In the study, a total of 806 subjects were randomized to receive either DefenCath or heparin as a CLS. Until now, patients who need hemodialysis 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.

DefenCath is an antimicrobial catheter lock solution (CL S) approved by the FDA to reduce the incidence of cat catheter-related bloodstream infections ("CRBSIs") for the limited population of adult patient with kidney failure receiving chronic he modialysis through a central venal catheter (CVC). In addition, FDA designated DefenCath as a Qualified Infectious Disease Product (QIDP) established by the Generating Antibiotic Incentives Now (GAIN) Act that supports development of antibacterial and antifungal products that treat serious or life-threatening infections. DefenCath has been designated by FDA as Fast-up, and FDA as Fast-up, a novel, non-antibiotic antimicrobial antimicrobial 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 identified by FDA as Fast-up and FDA as Fast-up and a Phase 3 clinical study.