FDA Accepts Resubmission of DefenCath New Drug Application by CorMedix Inc

CorMedix Inc. Clears Major Hurdle as FDA Accepts Resubmission of DefenCath New Drug Application

CorMedix Inc., a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions, today announced that the resubmission of the New Drug Application (NDA) for DefenCath has been accepted for filing by the U.S. Food and Drug Administration (FDA). The Agency considers the resubmission as a complete, Class 2 response with a six-month review, and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 15, 2023.

CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. The Company is focused on developing its lead product DefenCath™, a novel, non-antibiotic antimicrobial and antifungal solution designed to prevent costly and life-threatening bloodstream infections associated with the use of central venous catheters in patients undergoing chronic hemodialysis. DefenCath has been designated by FDA as Fast Track and as a Qualified Infectious Disease Product (QIDP), and the original New Drug Application (NDA) received priority review in recognition of its potential to address an unmet medical need. QIDP provides for an additional five years of marketing exclusivity, which will be added to the five years granted to a New Chemical Entity upon approval of the NDA.

DefenCath is being developed as a catheter lock solution with an initial indication of use for the reduction of catheter-related bloodstream infections (CRBSIs) in patients with kidney failure who are receiving chronic hemodialysis via a central venous catheter.

Joe Todisco, Chief Executive Officer of CorMedix, commented, “the acceptance of our DefenCath NDA resubmission marks an important milestone for CorMedix as we continue to work toward our efforts to reduce the risks associated with receiving hemodialysis via a central venous catheter. We appreciate the hard work of the broader CorMedix team as well as our strategic partners. As CorMedix continues to ramp up our preparations for a potential commercial launch, we expect to provide additional updates over the coming months.”

Published on : 22nd June, 2023