FDA approves new drug under special pathway for patients receiving hemodialysisFDA approves new drug under special pathway for patients receiving hemodialysis

Action

The U.S. Food and Drug Administration has approved Defencath (taurolidine and heparin) catheter lock solution (CLS) to reduce catheter-related bloodstream infections in adult patients with kidney failure who are receiving chronic hemodialysis (HD) through a central venous catheter (CVC). Defencath is indicated in this limited and specific patient population.

Defencath CLS is available as a sterile, preservative-free, clear, aqueous-based solution in 3ml and 5ml dosages. Additional details about dosage and administration are detailed in the prescribing information.

Disease or Condition

Renal failure results in inability of the kidneys to excrete waste products and extra water from the body. To replace the kidney function, patients with renal failure must adopt a treatment option which includes hemodialysis, peritoneal dialysis or kidney transplant.

Hemodialysis is a treatment to filter wastes and extra water from the blood. Patients undergoing hemodialysis often use a catheter for the filtration process which can lead to risk of bloodstream infection. Reducing the risk of microbial infection through a patient’s catheter can reduce the risk of bloodstream infections.

Effectiveness

Defencath was studied in a single, randomized, active-controlled phase 3 clinical trial. In this trial, Defencath delayed the time it took to acquire a catheter related bloodstream infection (CRBSI). Defencath demonstrated a 71% risk reduction in CRBSIs versus the heparin comparator arm (95% confidence interval for risk reduction: 38% to 86%; p value = 0.0006).

Safety Information

Defencath is intended for use as a catheter lock solution only and is not meant to be injected into the body or used as a catheter lock flush product. Each Defencath single-dose vial is designed for use with a single patient as a single instillation in the CVC.

Defencath has warnings for:

Heparin-Induced Thrombocytopenia (HIT): HIT is an adverse drug reaction that can cause life-threatening clotting in veins and arteries. The condition was reported in 0.3% of patients using heparin, a component of Defencath, as a catheter lock solution in the clinical trial. If HIT occurs, discontinue Defencath, and start appropriate medical treatment.

Drug hypersensitivity reactions: drug hypersensitivity reactions were reported in 0.5% of patients in clinical trial. If a hypersensitivity reaction occurs, discontinue Defencath and institute appropriate supportive measures.

The most frequently reported adverse reactions were hemodialysis catheter malfunction, hemorrhage/bleeding, nausea, vomiting, dizziness, musculoskeletal chest pain, and thrombocytopenia. See full prescribing information for additional details on safety and risks associated with Defencath.

Designation

This application is the third drug approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD). Defencath received both a fast-track and Qualified Infectious Disease Product Designation.

CZ vial

RTU(ready to use) 2ml COP vial

Source from FDA: https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-new-drug-under-special-pathway-patients-receiving-hemodialysis