The FDA Approved A New Medication To Prevent A Common Hospital Infection

People who are hospitalized, especially in intensive care, are often given a central venous catheter (aka a “central line”) — tubes placed in veins close to the heart to deliver the medications and fluids necessary for their recovery. Because these central lines are often needed for long periods of time (up to a year in some situations), they are difficult to keep sterile and infections through them are common, costly and potentially deadly. The Department of Health and Human Services estimates there are between 84,000 and 204,000 such infections annually, and as many as 25,000 related deaths, costing the healthcare system up to $21 billion a year.

This is where New Jersey-based CorMedix comes in. The company has developed a liquid that can be injected into the central line when it’s not being used that helps prevent central line infections from occurring. In phase 3 clinical trials, the company’s DefenCath “catheter lock solution” inspired a significant reduction in risk of acquiring infection compared to the standard of care.

On Wednesday, the FDA approved DefenCath for patients undergoing kidney dialysis, which will allow CorMedix to move forward with its plans to commercialize the product. CEO Joe Todisco told Forbes he expects the first shipments to hit the market by the end of the first quarter 2024 as it finalizes discussions with the Centers for Medicare and Medicaid Services about how the product should be reimbursed (most dialysis patients are on Medicare). “We’ve been in dialogue with them for several months so hopefully they have everything they need,” he said.

DefenCath is comprised of two different drugs. The first is heparin, an anti-blood clotting solution that’s commonly used in catheters when they’re not otherwise in use to prevent potentially dangerous clots from forming. The second is taurolidine, a proprietary chemical developed by CorMedix that acts as a broad-spectrum antimicrobial agent against a wide range of bacteria.

Prior to submitting its application to the FDA, the company used a randomized, double-blinded control study to determine the effectiveness of the drug. A total of 806 patients were given either heparin (the standard of care) or DefenCath. The patients who received DefenCath had much lower rates of infections than the control group, corresponding to about a 71% reduction in risk with no significant safety issues.

“If we can replicate that in the real world. It’s not just an impact on healthcare costs,” Todisco said. “When you think about what we can do to reduce incidence and mortality, we think we have the potential to have a sizeable impact on this community.”

At Wednesday’s market close, CorMedix’s stock was at $3.33, an increase of over 6% on the day.

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