There is so much to touch on in terms of what human beings can do well, and yet we still cannot do anything better than growing on a consistent basis. This progressive approach, on our part, has already got the world to hit upon some huge milestones, with technology appearing as a major member of the stated group. The reason why technology enjoys such an esteemed stature among people is, by and large, predicated upon its skill-set, which ushered us towards a reality that nobody could have ever imagined otherwise. Nevertheless, if we look up close for a second, it will become clear how the whole runner was also very much inspired from the way we applied those skills across a real world environment. The latter component was, in fact, what gave the creation a spectrum-wide presence, and consequentially, kickstarted a tech revolution. Of course, this revolution then went on to scale up the human experience through some outright unique avenues, but even after achieving such a monumental feat, technology will somehow continue to produce the right goods. The same has grown increasingly evident over the recent past, and assuming one new healthcare-themed development shakes out just like we envision, it will only make that trend bigger and better moving forward.
CorMedix, a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases, has officially bagged FDA’s (US Food and Drug Administration) approval for its catheter lock solution (CLS) called DefenCath. According to certain reports, the stated solution is geared towards reducing the incidence of catheter-related bloodstream infections (CRBSIs) in patients who are suffering from kidney failure. You see, these patients have to receive chronic hemodialysis through a central venous catheter (CVC), a treatment medium which has historically led to CRBIs. Talk about the severity of this disease, nearly 80% of patients starting hemodialysis will have a CVC inserted for vascular access. Now, put that information alongside how CRBSI’s can occur in up to a third of HD-CVC patients, and making the picture even grimmer is the fact that over 50% of CRBSIs occur within the first 3 months following CVC insertion. To give you holistic numbers, more than 250,000 CRBSIs occur in patients who have an intravascular device inserted like the one we just referred to. Out of these, one in every four patients has reportedly died due to this very infection. Not just death, though, CRBSI can also cause more hospital admissions, longer stays, and long-term complications, such as cardiovascular events. One reason why the disease in question is able to birth so much wreak-havoc is because CRBSIs in hemodialysis emerge from a wide range of pathogens, pathogens that are understood to be largely antibiotic-resistant.
“Patients and their loved ones have faced many burdens related to kidney failure, including complications caused by catheter related bloodstream infections and associated loss of work, severe disability and death. 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,” said Edward V. Hickey, III, President of the American Association of Kidney Patients and Chair of the Veterans Health Initiative.
But how exactly will the drug solve a problem which has looked unsolvable so far? Well, designed to occupy the catheter lumen in between sessions of dialysis, DefenCath bets on non-antibiotic antimicrobial and antifungal agents in anticoagulant heparin and taurolidine to do the job. The validation for picking these agents would notably come through a randomized, double-blind, active control, multicenter pivotal Phase 3 LOCK-IT-100 clinical trial. During the stated study, we had over 806 participants who were either administered DefenCath or heparin alone. Going by the available details, participants in the DefenCath group had a lower incidence of CRBSI events compared to patients in the control group. Boasting a hazard ratio of just 0.29, this group achieved a whopping 71% reduction in risk of developing CRBSI. If we contextualize the significance of the stated numbers, they surpassed established benchmarks by such a big margin that FDA classified it as Fast Track, thus giving the drug’s original New Drug Application (NDA) priority review in recognition of its potential to address an unmet medical need. With regulatory procedures now duly completed, CorMedix is planning to release DefenCath in the first quarter of 2024. Furthermore, while all the tests till now have focused on using the drug in adults, the company has already initiated the work to prepare it for use in other patient populations.
“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. As the first FDA-approved antimicrobial catheter lock solution designed to prevent CRBSIs, DefenCath offers healthcare providers an option to reduce the risk of infections in a patient population already vulnerable due to underlying kidney failure. We thank all the patients, caregivers, clinical investigators, and our employees who have played an integral role in the development and regulatory approval of DefenCath,” said Joseph Todisco, Chief Executive Officer of CorMedix.