Defencath is indicated for the prevention and therapy of catheter-related bloodstream infections in adults with kidney failure administered persistent hemodialysis through a central venous catheter.
The FDA has accepted CorMedix Inc’s Defencath (taurolidine and heparin) catheter lock answer (CLS) for the prevention and therapy of catheter-related bloodstream infections (CRBSIs) in adults with kidney failure administered persistent hemodialysis through a central venous catheter (CVC).1
The sterile, preservative-free, clear, aqueous-based Defencath is the now first and solely antimicrobial CLS accepted in the USA.
“The approval of DefenCath marks a significant development in decreasing life-threatening infections for sufferers receiving hemodialysis through central venous catheters and an essential milestone for CorMedix,” stated Joseph Todisco, chief government officer of CorMedix, in a press launch.2 “As the primary FDA-approved antimicrobial catheter lock answer designed to stop CRBSIs, DefenCath affords healthcare suppliers an choice to scale back the chance of infections in a affected person inhabitants already weak as a consequence of underlying kidney failure. We thank all of the sufferers, caregivers, medical investigators, and our staff who’ve performed an integral position within the improvement and regulatory approval of DefenCath. Our industrial crew together with our broader group is making ready for industrial launch, and we look ahead to working with healthcare suppliers and amenities to present hemodialysis sufferers entry to DefenCath in early 2024.”
The approval of DefenCath was primarily based on findings from the Section 3 LOCK-IT-100 medical examine. The randomized, double-blind, lively management, multicenter trial analyzed the efficacy and security of DefenCath in reducing CRBSI incidence in sufferers with kidney failure present process persistent hemodialysis.
Investigators randomly assigned 806 sufferers to obtain both DefenCath or heparin as a CLS. Sufferers utilizing DefenCath confirmed a decrease incidence of CRBSIs vs. sufferers within the management cohort, with a statistically important 71% drop within the danger of creating a CRBSI. LOCK-IT-100 was really helpful for an early termination primarily based on the demonstrated efficacy and a pre-specified degree of statistical significance with no security issues by an unbiased Information Security and Monitoring Board.
Adversarial occasions (AEs) had been discovered to be related in each the therapy and management cohorts. Amongst potential AEs, 0.3% of sufferers administered Defencath skilled heparin-induced thrombocytopenia (HIT), which may result in life-threatening clotting in veins and arteries. The FDA advises to stop therapy with Defencath ought to HIT happen and to start therapy with a unique remedy.
Hypersensitivity reactions had been reported in 0.5% of sufferers within the examine, wherein case the FDA stated use of Defencath needs to be discontinued. Different potential AEs embody hemodialysis catheter malfunction, hemorrhage/bleeding, nausea, vomiting, dizziness, and musculoskeletal chest ache.
Renal failure is attributable to the lack of the kidneys to filter out waste merchandise and extra water from the physique. To deal with the situation, sufferers sometimes bear hemodialysis, peritoneal dialysis, or a kidney transplant. Hemodialysis filters waste and extra water from the blood and sometimes requires a catheter for the filtration course of, which may result in an elevated bloodstream an infection danger.
“Sufferers and their family members have confronted many burdens associated to kidney failure, together with issues attributable to catheter associated bloodstream infections and related lack of work, extreme incapacity and dying,” stated Edward V. Hickey, III, president of the American Affiliation of Kidney Sufferers and Chair of the Veterans Well being Initiative, in a press launch.2 “Till now, sufferers who want hemodialysis through a central venous catheter have had little selection apart from to simply accept excessive an infection dangers related to the prevailing commonplace of care. The FDA’s approval of DefenCath is a significant second for sufferers and their healthcare suppliers as a result of they now have a brand new different to scale back the dangers of CRBSIs.”
References
1. FDA Approves New Drug Beneath Particular Pathway for Sufferers Receiving Hemodialysis. U.S. Meals & Drug Administration. November 15, 2023. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-new-drug-under-special-pathway-patients-receiving-hemodialysis?utm_medium=email&utm_source=govdelivery. Accessed November 15, 2023.
2. CorMedix Inc. Broadcasts FDA Approval of DefenCath® to Cut back the Incidence of Catheter-Associated Bloodstream Infections in Grownup Hemodialysis Sufferers. CorMedix Inc. Information launch. Revealed November 15, 2023. Accessed November 15, 2023. https://www.globenewswire.com/news-release/2023/11/15/2781334/0/en/CorMedix-Inc-Announces-FDA-Approval-of-DefenCath-to-Reduce-the-Incidence-of-Catheter-Related-Bloodstream-Infections-in-Adult-Hemodialysis-Patients.html