FDA approves DefenCath for adults with kidney failure on chronic hemodialysis
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Key takeaways:
- The approval comes after results of the phase 3 LOCK-IT-100 clinical trial.
- DefenCath reduced the risk of catheter-related bloodstream infections by up to 71%.
The FDA has approved DefenCath, a catheter lock solution of taurolidine and heparin by CorMedix Inc., for adults with kidney failure on chronic hemodialysis, according to a press release.
The antimicrobial treatment is intended for patients who receive chronic hemodialysis through a central venous catheter, according to a press release from CorMedix Inc.
“The approval of DefenCath marks a major advancement in reducing life-threatening infections for patients receiving hemodialysis via central venous catheters,” Joseph Todisco, CEO of the biopharmaceutical company, said in the release. “DefenCath offers health care providers an option to reduce the risk of infections in a patient population already vulnerable due to underlying kidney failure.”
The approval comes after results of the phase 3 LOCK-IT-100 clinical trial. The multicenter, double-blind, active control study included 806 patients randomly selected to receive either DefenCath (taurolidine and heparin) or heparin as a catheter lock solution.
Results showed patients in the DefenCath group had a lower incidence of catheter-related bloodstream infections vs. controls, and the therapy reduced risk by up to 71%. Adverse events were similar between groups, according to the findings.
DefenCath is comprised of heparin and taurolidine, as well as a broad-spectrum non-antibiotic antimicrobial and antifungal agent, according to CorMedix. The treatment is designed to occupy the catheter lumen in between dialysis sessions.
“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,” Edward V. Hickey III, president of the American Association of Kidney Patients and chair of the Veterans Health Initiative, said in the release. The greenlight from the FDA “is a meaningful moment for patients and their health care providers because they now have a new alternative to reduce the risks of [catheter-related bloodstream infections] CRBSIs.”
CorMedix aims to make the solution available for patients on hemodialysis in early 2024, according to the release.
Reference:
FDA approves new drug under special pathway for patients receiving hemodialysis. 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. Published Nov. 15, 2023. Accessed Nov. 15, 2023.
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