CorMedix Announces FDA Acceptance of New Drug Application for Defencath

CorMedix announced the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s submitted New Drug Application (NDA) for Defencath™, its product candidate to be used as a catheter lock solution in hemodialysis patients for the prevention of catheter related blood stream infections (CRBSI). The FDA had previously granted a rolling submission and review, which the Company completed at the end of June. The FDA also granted priority review and set a Prescription Drug User Fee Act (PDUFA) date of February 28, 2021 for the completion of its review for approval of the NDA. The Agency noted that it is planning to hold an advisory committee meeting to discuss the application and that it had not identified any potential review issues at this time.

“The NDA acceptance is truly a momentous achievement for CorMedix, the internal and external teams involved with the submission, and most importantly, the hemodialysis patient community. We are proud of our team for exceptional effort to get us to this point and look forward to bringing Defencath to patients to prevent the serious complications and costs associated with CRBSI in this significant patient population,” Khoso Baluch, CorMedix CEO said.

“Having been actively involved with the Defencath program and regulatory journey for the past several years, it is very rewarding to have the FDA’s acceptance of our first NDA as an essential step toward our goal of offering Defencath in the U.S. as the first antimicrobial catheter lock solution for the prevention of life-threatening CRBSI in hemodialysis patients. We are very appreciative that the Agency granted priority review and despite the ongoing pandemic, we look forward to continuing to work together expeditiously to complete the review of the Defencath NDA to address an unmet medical need,” Phoebe Mounts, CorMedix Executive Vice President and General Counsel, further said.

The FDA grants priority review to applications for potential therapies that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions when compared to standard applications. CorMedix included in the Defencath NDA submission positive results from the 795 patient LOCK-IT-100 clinical trial, which demonstrated a good safety profile and a highly statistically significant reduction of 71% (p=0.0006) in CRBSI in patients undergoing hemodialysis compared to heparin, the current standard of care. Defencath had been granted Fast Track and Qualified Infectious Disease Product (QIDP) designations by the FDA, which provided eligibility to request priority review of the NDA.