Today, CorMedix announced its request for a
label expansion for Neutrolin®, its catheter lock solution, had been approved
by TUV-SUD and The Medicinal Evaluation Board of the Netherlands (MEB). Neutrolin®
was initially approved in July 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.
CorMedix’s label expansion extended approval
for three elements:
• Approval
for additional indications for use in oncology patients receiving chemotherapy,
IV hydration, and IV medications via central venous catheters
• Approval
for 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)
• Approval
for an additional indication for use in total parenteral nutrition
CorMedix anticipates this will lead to
additional critically ill patients benefiting from the expanded use of
Neutrolin® to prevent infection and thrombosis. 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.
Randy Milby, Chief Executive Officer and Dr.
Antony Pfaffle, Chief Scientific Officer of CorMedix, stated, “We are very
pleased with the label expansion and the extended ability to treat patients
with urgent medical needs. We thank the regulatory authorities and our
regulatory advisors for their cooperation in achieving this significant
milestone.”
CorMedix Inc. is a commercial-stage
pharmaceutical company that seeks to in-license, develop and commercialize
therapeutic products for the prevention and treatment of cardiac, renal and
infectious diseases. CorMedix’s first commercial product in Europe is
Neutrolin®, a catheter lock solution for the prevention of catheter related
bloodstream infections and maintenance of catheter patency in tunneled, cuffed,
central venous catheters used for vascular access in hemodialysis patients, in
addition to oncology patients, critical care patients including neonates, and
patients receiving total parenteral nutrition, IV hydration, and/or IV
medications.
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