CorMedix has announced that the U.S. Food and Drug Administration (FDA) has granted approval for DefenCath® (taurolidine and heparin) catheter lock solution (CLS) for a specific group of adult patients undergoing chronic hemodialysis with a central venous catheter (CVC). This approval makes DefenCath the first FDA-approved antimicrobial CLS in the United States, shown to decrease the incidence of catheter-related bloodstream infections (CRBSIs) by up to 71% in a Phase 3 clinical study.

The approval of DefenCath represents a significant advancement in reducing life-threatening infections for patients receiving hemodialysis through central venous catheters, marking a crucial milestone for CorMedix. As the inaugural FDA-approved antimicrobial catheter lock solution designed for preventing CRBSIs, DefenCath provides healthcare providers with a valuable option to reduce infection risks in a patient population already vulnerable due to underlying kidney failure.

The FDA's approval was based on results from the LOCK-IT-100 clinical trial, a randomized, double-blind study assessing DefenCath's efficacy and safety in reducing CRBSI incidence in chronic hemodialysis patients with kidney failure. The study involved 806 subjects randomized to receive either DefenCath or heparin as a CLS, with the DefenCath group experiencing a significantly lower CRBSI incidence compared to the control group (Hazard Ratio of 0.29, representing a 71% risk reduction). The trial was terminated early based on demonstrated efficacy and a predetermined level of statistical significance, with no safety concerns raised by an independent Data Safety and Monitoring Board. Adverse events were comparable to the control group.

Until now, patients requiring hemodialysis through a central venous catheter had limited options, exposing them to high infection risks associated with the existing standard of care. The approval of DefenCath is a meaningful development for patients and healthcare providers, offering a new alternative to mitigate the risks of CRBSIs. This emphasizes the importance of continued research and development in the biopharmaceutical sector to address critical healthcare needs and enhance patient outcomes.

Source: cormedix.com

 

 

 

 

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