CorMedix Gets FDA Feedback on Label Expansion

CorMedix Inc., a biopharmaceutical company specializing in the development and commercialization of therapeutic products for severe diseases, has received feedback from the U.S. Food and Drug Administration (FDA) on its plans to develop additional indications for its product DefenCath. The company aims to expand DefenCath's use to adult patients receiving Total Parenteral Nutrition (TPN). CorMedix plans to submit a complete clinical protocol to the FDA by the third quarter of 2024, with the aim of aligning on the program and initiating it by the end of the year.

The FDA has also confirmed that CorMedix needs to conduct a study on pediatric hemodialysis (HD) patients as required by the Pediatric Research Equity Act (PREA). This study is intended to evaluate the prevention of Central Line Associated Blood Stream Infections (CLABSI) in adult TPN patients. CorMedix has engaged an independent party to conduct a market assessment, which revealed a critical need for DefenCath among TPN patients. The data indicates that over 25% of TPN patients suffer from CLABSI, with around 5 million infusions per year representing the total addressable market for DefenCath in TPN. Patients with CLABSI face higher rates of hospital admissions and significant increases in mortality.

The company's CEO, Joseph Todisco, expressed satisfaction with the FDA's feedback and highlighted the importance of advancing the development program for this vulnerable patient group. Todisco noted significant interest from clinical investigators in participating in the study and hopes to commence the TPN program by the end of 2024, pending timely FDA approval.

DefenCath, which contains taurolidine and heparin, is currently approved to reduce catheter-related bloodstream infections in adult patients with kidney failure undergoing chronic hemodialysis through a central venous catheter. However, it is important to note that DefenCath is contraindicated for patients with known heparin-induced thrombocytopenia or hypersensitivity to its components.

CorMedix plans to provide additional data on the TPN market opportunity during its second-quarter earnings call in August. The company has already launched DefenCath in inpatient settings in April 2024 and plans to extend the commercial launch to outpatient settings by July 2024.

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