CorMedix Inc., a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiac, renal and infectious disease, announced the approval of a label expansion from the Hessian District President in Germany for its lead product Neutrolin, a catheter lock solution.
Neutrolin was initially approved in Germany in December 2013 for use in the prevention of catheter-related bloodstream infections (CRBI) and maintenance of catheter patency in hemodialysis patients using a tunneled, cuffed central venous catheter for vascular access. This approval expands the label to include use in oncology patients receiving chemotherapy, IV hydration and IV medications via central venous catheters. The expansion also adds patients receiving medication and IV fluids via central venous catheters in intensive or critical care units (cardiac care unit, surgical care unit, neonatal critical care unit, and urgent care centers). An indication for use in total parenteral, or IV, nutrition was also approved.
In September 2014, the TUV-SUD and The Medicinal Evaluation Board of the Netherlands (MEB) granted a label expansion for Neutrolin for these same expanded indications for the EU. The active anti-infective ingredient in Neutrolin is taurolidine, which has efficacy against both common and resistant forms of bacteria and fungi. Despite a long history of clinical use, development of resistance has not been observed.
"With these label expansions, more highly vulnerable patients in the critical care, oncology and dialysis settings can be treated with Neutrolin for the prevention of infection and thrombosis," said Dr. Antony Pfaffle, chief scientific officer of CorMedix. "Our goal is to provide the optimal catheter care solution to improve the quality of clinical medical care for these patients."