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CorMedix Inc. Announces FDA Grant of Rolling Review of Neutrolin® New Drug Application
BERKELEY HEIGHTS, N.J., Feb. 03, 2020 (GLOBE NEWSWIRE) -- CorMedix Inc. (NYSE American: CRMD), a biopharmaceutical company focused on developing and
About this update from Cormedix Inc.
[{"type":"text","content":"BERKELEY HEIGHTS, N.J., Feb. 03, 2020 (GLOBE NEWSWIRE) -- CorMedix Inc. (NYSE American: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, announced today that the US Food and Drug Administration has granted the request for a rolling review of the New Drug Application (NDA) for Neutrolin® for the prevention of catheter-related blood stream infections (CRBSIs) in hemodialysis patients. Neutrolin has received Fast Track Designation from FDA and the Company confirmed with FDA in a pre-NDA meeting that it was eligible to request a rolling review. A rolling submission of the NDA is designed to expedite the review process for products being developed to address an unmet medical need. CorMedix remains on schedule for a potential NDA approval during the second half of 2020.\n Khoso Baluch, CorMedix Chief Executive Officer, commented, “We are very proud of the achievement by the CorMedix Team of reaching this significant milestone for Neutrolin. We are also grateful to FDA for its continuing cooperation, as we work diligently to secure regulatory approval of Neutrolin in the US to prevent life-threatening CRBSIs in hemodialysis patients.” About CorMedix CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases. The Company is focused on developing its lead product Neutrolin®, a novel, non-antibiotic antimicrobial solution designed to prevent costly and dangerous bloodstream infections associated with the use of central venous catheters. The Company completed a Phase 3 clinical trial of Neutrolin in patients undergoing hemodialysis for end-stage renal disease, which showed a 71% reduction in catheter-related bloodstream infections (CRBSIs) relative to the heparin control arm (p=0.0006) with a good safety profile. CRBSIs cost the U.S. healthcare system approximately $6 billion annually and contribute significantly to increased morbidity and mortality. Neutrolin has Fast Track designation from FDA, which provides the potential for priority review of a marketing application, and Qualified Infectious Disease Product designation, which allows for 5 additional years of marketing exclusivity when approved f...