FDA Approves CorMedix’s Defencath

FDA has approved CorMedix’s Defencath (taurolidine and heparin) catheter lock drug to reduce catheter-related bloodstream infections in adult patients with kidney failure who are receiving chronic hemodialysis through a central venous catheter. The agency says it is the third drug approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs.

Approval was based on data from a single Phase 3 trial that demonstrated Defencath delayed the time it took to acquire a catheter-related bloodstream infection (CRBSI), an agency release says. “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),” it says.

Regarding safety, FDA says Defencath has warnings for Heparin-Induced Thrombocytopenia (HIT) and drug hypersensitivity reactions. In the clinical trial, the most frequently reported adverse reactions were “hemodialysis catheter malfunction, hemorrhage/bleeding, nausea, vomiting, dizziness, musculoskeletal chest pain, and thrombocytopenia,” it adds.