CorMedix Inc. Announces FDA Approval of DefenCath® to Reduce the Incidence of Catheter-Related Bloodstream Infections in Adult Hemodialysis Patients
BERKELEY HEIGHTS, N.J., Nov. 15, 2023 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions, today announced that the U.S. Food and Drug Administration (FDA) has approved DefenCath® (taurolidine and heparin) catheter lock solution (CLS) to reduce the incidence of catheter-related bloodstream infections (CRBSIs) for the limited population of adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter (CVC). DefenCath is the first and only FDA-approved antimicrobial CLS in the U.S. and was shown to reduce the risk of CRBSIs by up to 71% in a Phase 3 clinical study.
- Joseph Todisco, Chief Executive Officer of CorMedix commented, “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.
- 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.
- In the study, a total of 806 subjects were randomized to receive either DefenCath or heparin as a CLS.
- Patients in the DefenCath group had a lower incidence of CRBSI events compared to patients in the control group.