June 16, 2024

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FDA Approves New Medication to Prevent Infections in Central Venous Catheters

FDA Approves New Medication to Prevent Infections in Central Venous Catheters



FDA Approves New Medication to Prevent Infections in Central Venous Catheters

Patients undergoing hospitalization, especially those in intensive care, often rely on Central Venous Catheters (CVC) for their treatment.

These catheters are inserted into veins close to the heart to provide a conduit for medications and fluids crucial to the patient’s recovery.

Due to the extended duration these central venous lines are often in place, up to a year in some cases, maintaining sterility becomes challenging, leading to frequent infections.

Such infections can be costly and, in some cases, fatal.

According to estimates from the U.S. Department of Health and Human Services, these infections occur between 84,000 and 204,000 times annually, resulting in approximately 25,000 deaths and a staggering annual healthcare cost of $21 billion.

FDA Approves New Medication to Prevent Infections in Central Venous Catheters

Addressing this issue is CorMedix, headquartered in New Jersey. The company has developed a solution: a medication that can be injected when the central venous line is not in use to prevent infections. In phase III clinical trials, CorMedix’s DefenCath Catheter Lock Solution demonstrated a significant reduction in infection risk compared to standard treatment.

On November 15, the U.S. Food and Drug Administration (FDA) granted approval for the use of DefenCath in patients undergoing kidney dialysis. This approval allows CorMedix to proceed with its product development plans. Joe Taddeo, CEO of CorMedix, told Forbes in an interview that the company is currently in discussions with Medicare and Medicaid (both public healthcare insurance programs in the U.S.) regarding coverage for the product. He expects the first shipments to the market by the end of the first quarter of 2024, stating, “We’ve been in discussions with them for several months, so we believe we have all the necessary information.”

DefenCath consists of two types of medications. The first is heparin, a commonly used anticoagulant when the catheter is not in use, preventing the formation of dangerous blood clots. The second is taurolidine, a chemical developed by CorMedix that acts as a broad-spectrum antibacterial agent against a wide range of bacteria.

Before applying to the FDA, the company determined the effectiveness of the drug through a randomized double-blind comparative trial. Of the total 806 patients, either heparin (standard treatment) or DefenCath (the new drug) was administered. Patients receiving DefenCath had a significantly lower infection rate compared to the control group, translating to an approximately 71% risk reduction, with no significant safety issues identified.

Taddeo stated, “If this can be replicated in the real world, it has the potential to make a significant impact on the industry not only in terms of healthcare costs but also by reducing the incidence and mortality rates.”

On November 15, CorMedix’s stock price rose by over 6%, closing at $3.33.

FDA Approves New Medication to Prevent Infections in Central Venous Catheters

(source:internet, reference only)


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