The Company recently submitted the New Drug Application (NDA) for Defencath™ to the Food and Drug Administration (FDA). The Company requested priority review of the NDA, based on the Fast Track and Qualified Infectious Disease Product Designations granted by FDA to Defencath. If Priority Review is granted, FDA will have a goal of a 6-month review of the NDA, compared to 10 months for a standard review.
Defencath is available in Europe and other territories under the brand name Neutrolin.
Defencath™ is a proprietary formulation of taurolidine 1.35%, citrate 3.5% and heparin 1000 units/mL that is currently being investigated for use as a catheter lock solution, with the aim of reducing the risk of infections from in-dwelling catheters. Taurolidine, the key compound in Defencath™, is an amino acid derivative with in-vitro studies indicating broad antimicrobial activity against gram-positive and gram-negative bacteria, including antibiotic resistant strains, as well as mycobacteria and clinically relevant fungi including Aspergillus.
Despite improvements and initiatives to control infection, catheter biofilm develops within 24 hours and can lead to life-threatening infections, costing the U.S. healthcare system billions of dollars annually. With an estimated 250,000 CRBSIs occurring annually in United States, it comes to no surprise that over 180 extensive interviews with nephrologists, oncologists, total parenteral nutrition (TPN) healthcare providers have indicated a significant unmet need in addressing CRBSIs.
Based on independent research, the current estimate of the annual need for catheter lock solutions (CLS) in the United States for hemodialysis alone is approximately 80 million vials. Additionally, meeting the needs in other indications, such as oncology and TPN, may require up to an estimated several hundred million more vials per year. CorMedix is conducting research to explore additional settings, such as the intensive care unit (ICU), for the potential uses of CLSs.
Defencath™ in the United States
Defencath™ has finished its Phase 3 clinical study, known as LOCK-IT-100. The primary objective of the LOCK-IT-100 clinical study was to demonstrate the efficacy and safety of Defencath™ as a catheter lock solution (CLS) for prevention of catheter-related bloodstream infection (CRBSI) in subjects receiving hemodialysis (HD) for the treatment of End Stage Renal Disease (ESRD) when compared with heparin.
Currently, there are no pharmacological agents approved in the United States for the prevention of CRBSIs. In January 2015, the U.S. Food and Drug Administration (FDA) granted Fast Track and Qualified Infectious Disease Product (QIDP) designations for Defencath™.
The Fast Track designation provides CorMedix with the opportunity to meet with the FDA on a more frequent basis during the development process, and provides eligibility to request priority review of the marketing application.
QIDP designation is assigned to drug products intended to treat serious or life-threatening infections. Importantly, QIDP designation provides an additional five years of market exclusivity in addition to the five years granted for a New Chemical Entity.