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CorMedix Inc. Receives FDA Feedback on Potential Label Expansion
BERKELEY HEIGHTS, N.J., June 18, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing
About this update from Cormedix Inc.
[{"type":"text","content":"BERKELEY HEIGHTS, N.J., June 18, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced that the U.S. Food and Drug Administration (FDA) has provided feedback to the Company’s request to discuss development plans for additional indications for DefenCath. The FDA provided supportive feedback regarding the Company’s plans to pursue an expanded indication in adult Total Parenteral Nutrition (TPN) patients. CorMedix expects to submit a complete clinical protocol to FDA in the 3rd quarter with a goal of gaining further alignment and initiating the program by the end of 2024. In addition, the FDA confirmed its requirement that the Company conduct a study in pediatric hemodialysis (HD) patients under the Pediatric Research Equity Act (PREA). CorMedix intends to pursue the development of DefenCath for the expanded indication of the prevention of Central Line Associated Blood Stream Infections (CLABSI) in adult patients receiving TPN through a central venous catheter. The Company recently engaged an independent third party to conduct a TPN market assessment, and based on their analysis, believes there is a critical unmet medical need for DefenCath in this patient population. The data estimates the rate of CLABSI in TPN patients to be greater than 25%, and that the total addressable market for DefenCath in TPN is driven by approximately 5 million infusions per year. Patients receiving TPN that contract a CLABSI experience materially higher rates of hospital admission and readmission, as well as significant increases in patient mortality. CorMedix intends to share additional data related to the TPN market opportunity on the Company’s second quarter earnings call in August. Joseph Todisco, CorMedix CEO, commented, “I am pleased with FDA’s feedback and am excited about the opportunity to advance a development program for this highly vulnerable patient population. Given the high rate of CLABSI in patients receiving TPN, we have seen significant inbound interest for study participation by clinical investigators. Provided we obtain FDA’s concurrence on the final study protocol in a timely manner, we hope to commence a TPN program before the end of 2024.” DefenCath® (taurolidine and heparin)IMPO...