CorMedix Inc. Receives FDA Feedback on Potential Label Expansion
CorMedix (NASDAQ: CRMD) has received supportive feedback from the FDA regarding its plans to expand the use of DefenCath to adult Total Parenteral Nutrition (TPN) patients. The company plans to submit a complete clinical protocol by the third quarter of 2024 and aims to start the program by year-end. The FDA also requires a pediatric study under the Pediatric Research Equity Act. An independent market assessment shows a critical unmet need for DefenCath in TPN patients, with an estimated CLABSI rate over 25% and an addressable market of 5 million yearly infusions. Further details will be shared in CorMedix's Q2 earnings call in August.
- FDA provided supportive feedback on expanded DefenCath indication for adult TPN patients.
- Submission of clinical protocol expected by Q3 2024.
- Potential program initiation by end of 2024.
- Independent market assessment indicates critical unmet need in TPN patients.
- Estimated addressable market: 5 million TPN infusions per year.
- High CLABSI rate (>25%) in TPN patients indicates significant market opportunity.
- Positive interest from clinical investigators for study participation.
- FDA requires a study in pediatric hemodialysis (HD) patients under PREA.
- Development dependent on timely FDA concurrence on study protocols.
- DefenCath currently to specific population (chronic HD through CVC).
- Existing drug contraindications and warnings for certain patient groups.
Insights
The recent feedback from the FDA regarding CorMedix Inc.'s (CRMD) expansion plans for DefenCath is noteworthy. This product already addresses a significant medical need by reducing catheter-related bloodstream infections (CRBSI) in hemodialysis patients. The plan to expand its use to patients receiving Total Parenteral Nutrition (TPN) can have substantial implications. TPN patients are highly susceptible to Central Line Associated Blood Stream Infections (CLABSI) and DefenCath could potentially reduce the complication rates, leading to fewer hospital admissions and lower mortality rates.
Key Insight: The FDA's supportive stance on the expanded indication suggests the data and rationale provided by CorMedix were compelling. This can expedite the clinical development pathway, positioning DefenCath favorably in a market with an estimated 5 million annual TPN infusions. The high rate of CLABSI in TPN patients, greater than
However, the requirement to conduct additional studies in pediatric hemodialysis patients under the Pediatric Research Equity Act (PREA) adds another layer of complexity and time to the overall development timeline. Balancing adult and pediatric study demands will be critical for CorMedix moving forward.
The FDA's feedback opens new market opportunities for CorMedix. The expanded indication for DefenCath targets a critical unmet medical need in the TPN patient population. Conducting a market assessment to understand the potential demand is a strategic move. The estimated addressable market, driven by approximately 5 million annual infusions, presents a promising revenue stream if the FDA grants approval for this expanded use.
Potential Market Impact: Given the significant incidence of CLABSI in TPN patients, exceeding
However, investors should watch for CorMedix's ability to effectively navigate the regulatory requirements and manage additional studies, particularly in the pediatric population. Any delays or setbacks in this process could impact the anticipated market entry timeline and associated revenue projections.
From a financial perspective, the FDA's feedback is encouraging for CorMedix's future growth prospects. If the expanded indication for DefenCath in TPN patients leads to approval, it could significantly enhance the company's revenue streams. The current estimated market size and high infection rates provide a strong financial incentive for the company to pursue this indication.
Financial Implications: The market potential, combined with the estimated high rate of CLABSI, suggests a strong demand for DefenCath. Successful expansion into the TPN market could result in increased sales and improved financial performance for CorMedix.
However, investors should remain cautious about the costs associated with additional clinical trials, especially those required under PREA. These expenses could weigh on short-term financials. It will be vital to monitor CorMedix’s financial management and fundraising activities as they move towards these ambitious development goals.
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
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)
IMPORTANT SAFETY INFORMATION
These highlights do not include all the information needed to use DefenCath safely and effectively. See full prescribing information for DefenCath.
LIMITED POPULATION: DefenCath is indicated to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC). This drug is indicated for use in a limited and specific population of patients.
DefenCath is contraindicated and has warnings and precautions in patients with:
- Known heparin-induced thrombocytopenia (HIT).
- Known hypersensitivity to any drug products in DefenCath, including taurolidine, heparin or the citrate excipient or pork products.
If exposure to either of the above occurs, discontinue use of DefenCath and institute appropriate supportive measures.
To report any safety concerns including suspected adverse reactions, contact CorMedix Inc. at 1-888-424-6345 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
Please see the full Prescribing Information.
About CorMedix
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 commercializing its lead product DefenCath®, which was approved by the FDA on November 15, 2023 and launched in inpatient settings in April 2024. CorMedix anticipates the commercial launch of DefenCath in outpatient settings in July 2024. CorMedix also intends to develop DefenCath as a catheter lock solution for use in other patient populations. For more information visit: www.cormedix.com.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are subject to risks and uncertainties. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “will,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would,” and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects should be considered forward-looking statements. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this press release. Investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.
Investor Contact:
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FAQ
What feedback did CorMedix receive from the FDA regarding DefenCath?
When does CorMedix plan to submit the clinical protocol for DefenCath?
What is the estimated addressable market for DefenCath in TPN patients?
What is the CLABSI rate in TPN patients?
What additional study does the FDA require for DefenCath?
When will CorMedix share additional data related to the TPN market opportunity?
What is the planned timeline for starting the DefenCath program in TPN patients?
