– First and only FDA-approved antimicrobial catheter lock solution in the
– Company expects DefenCath to be available in Q1 2024 in the inpatient setting
The FDA approval of DefenCath was supported by results from the randomized, double-blind, active control, multicenter pivotal Phase 3 LOCK-IT-100 clinical trial designed to assess the efficacy and safety of DefenCath for reducing the incidence of CRBSIs in patients with kidney failure receiving chronic hemodialysis. 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. The Hazard Ratio was 0.29, corresponding to a statistically significant 71% reduction in risk of developing a CRBSI. An independent Data Safety and Monitoring Board recommended an early termination of the study based on demonstrated efficacy and a pre-specified level of statistical significance with no safety concerns. Adverse events were comparable to control.
About Catheter-Related Bloodstream Infections
Catheter-related bloodstream infections (CRBSIs) are common in patients with central venous catheters (CVCs). Approximately 80% of patients starting hemodialysis will have a CVC inserted for vascular access. CRBSI’s can occur in up to a third of HD-CVC patients and over 50% of CRBSIs occur within the first 3 months following CVC insertion. Each year, ~250,000 CRBSIs occur in patients with an intravascular device, such as central venous catheters (CVCs), leading to death in about one in four patients infected. CRBSIs can lead to more hospital admissions, longer stays, and long-term complications such as cardiovascular events. CRBSIs in hemodialysis are caused by a wide range of pathogens, many of which are antibiotic-resistant.
About DefenCath® (taurolidine and heparin) Catheter Lock Solution
DefenCath is an antimicrobial catheter lock solution (CLS) approved by the FDA 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). It is comprised of the anticoagulant heparin and taurolidine, a broad-spectrum non-antibiotic antimicrobial and antifungal agent. DefenCath is designed to occupy the catheter lumen in between sessions of dialysis. Microbial resistance to taurolidine has not been documented in the laboratory or in clinical use in
Indication and Important Safety Information for DefenCath
DefenCath was approved pursuant to the limited population for antibacterial and antifungal drugs (LPAD) pathway established by the 21st Century Cures Act to address unmet needs of patients with serious bacterial and fungal infections. In addition, FDA designated DefenCath as a Qualified Infectious Disease Product (QIDP) established by the Generating Antibiotic Incentives Now (GAIN) Act that supports development of antibacterial and antifungal products that treat serious or life-threatening infections. FDA approved DefenCath to reduce the incidence of catheter-related bloodstream infections in adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter. It is indicated for use in a limited and specific population of patients. The safety and effectiveness of DefenCath have not been established for use in populations other than adult patients with kidney failure receiving chronic HD through a CVC.
DefenCath contains taurolidine, a thiadiazinane antimicrobial and heparin, an anticoagulant, which can induce thrombocytopenia or HIT, and is contraindicated and should not be used in patients with known HIT or hypersensitivity to taurolidine, heparin or citrate. It is not intended for systemic administration. DefenCath must be aspirated from the catheter and discarded prior to the initiation of the next hemodialysis session.
The mean age of patients in LOCK-IT-100 was 61 years, 58% of patients identified as male, 42% identified as female, 63% as white and 30% as black or
The most frequently reported adverse reactions occurring in ≥ 2% of patients in LOCK-IT-100 using DefenCath as a catheter lock solution were hemodialysis catheter malfunction, hemorrhage/bleeding, nausea, vomiting, dizziness, musculoskeletal chest pain, and thrombocytopenia. Adverse reactions leading to death occurred in 5% (18/398) of patients in the DefenCath arm and 5% (21/399) in the heparin arm. Adverse reactions leading to discontinuation of study drug occurred in 17% (69/398) in the DefenCath arm and 18% (72/399) in the heparin arm.
The safety and effectiveness of DefenCath have not been established for use in populations other than adult patients with kidney failure receiving chronic hemodialysis through a CVC. DefenCath is not intended for systemic administration and therefore maternal use is not expected to result in fetal exposure to the drug and breast feeding is not expected to result in exposure of the infant. No animal reproduction study was conducted with DefenCath. The safety and effectiveness of DefenCath have not been established in pediatric patients. No overall differences in safety or effectiveness were observed between patients 65 years of age and older and younger adult patients.
FDA Announcement
FDA approves new drug under special pathway for patients receiving hemodialysis | FDA
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