CorMedix Submits Defencath New Drug Application

CorMedix announced all of the modules for the Defencath™ New Drug Application (NDA) have been submitted to the Food and Drug Administration (FDA). Defencath is being developed as a catheter lock solution with an initial indication for use of preventing catheter-related bloodstream infections (CRBSIs) in patients with end-stage renal disease who are receiving hemodialysis via a central venous catheter. The NDA was granted rolling submission and review by FDA as announced previously, and there has been ongoing dialogue with FDA as it reviews the submitted modules. The NDA contained data from the Company’s Phase 3 trial, LOCK-IT-100, in patients undergoing hemodialysis for end-stage renal disease, which showed a 71% reduction in CRBSIs relative to the heparin control arm (p=0.0006) with a good safety profile.

The Company requested priority review of the NDA, based on the Fast Track and Qualified Infectious Disease Product Designations granted by FDA to Defencath. The FDA has 60 days to review the submission for completeness to make a filing decision and grant a priority or standard review.  FDA will have a goal of a 6 month review period for priority review, compared to 10 months for a standard review.

“I would like to thank the team for their tremendous effort to get us to the submission of the NDA last week.  We are very pleased to have completed the submission of the NDA, despite the limitations imposed by the COVID-19 pandemic, which delayed some required laboratory testing and our submission. Submission of our first NDA is an important milestone for CorMedix and is a significant accomplishment by the Company.  We look forward to being able to launch Defencath into the hemodialysis market to address a significant unmet medical need. We will continue to consider all strategic options. We will make an announcement when the FDA has made a filing decision and a potential approval date has been determined by FDA,” Khoso Baluch, CorMedix CEO said.