FDA approves drug to prevent dialysis-related bloodstream infections

Defencath (taurolidine and heparin) catheter lock solution is indicated to reduce catheter-related bloodstream infections (CRBSIs) in adults with kidney failure receiving chronic hemodialysis via a central venous catheter. The drug was approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs and is only indicated in this limited and specific patient population. Approval was based on data from the phase 3 LOCK-IT-100 trial in which Defencath demonstrated a 71% risk reduction in CRBSIs vs. the heparin comparator arm.