CorMedix Inc. Announces U.S. Inpatient Commercial Availability of DefenCath® (Taurolidine and Heparin)
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The introduction of CorMedix Inc's DefenCath to the U.S. inpatient market represents a noteworthy development within the pharmaceutical industry, particularly pertaining to the management of catheter-related bloodstream infections (CRBSIs). The drug's approval by the FDA underscores its promise in reducing the prevalence of CRBSIs among patients undergoing chronic hemodialysis via central venous catheters. The unique combination of taurolidine and heparin offers a dual approach to infection control and anticoagulation, which could feasibly lead to improved patient outcomes.
Assessing the potential market impact, it is significant to note that chronic kidney disease affects a considerable patient population in the U.S., with a portion relying on hemodialysis. By targeting this specific medical need, CorMedix taps into a specialized sector that may have been underserved by previous treatment options. The company's outreach to healthcare providers could encourage rapid adoption in clinical settings. However, the true measure of commercial success will likely hinge on the outcomes observed in real-world use, the drug's cost-effectiveness and its integration into clinical protocols.
CorMedix Inc.'s DefenCath's availability in the inpatient setting can have immediate economic implications for healthcare facilities by potentially reducing the expenses associated with managing CRBSIs, which are often significant. The prevention of such infections aligns with the broader objective of cost-saving in healthcare through reduced hospitalization durations and minimized need for repeat medical interventions.
Long-term, the planned outpatient commercial availability could see a broader economic effect, contingent upon the Center for Medicare & Medicaid Services (CMS) approval for the Transitional Drug Add-On Payment Adjustment (TDAPA). The TDAPA's role in providing additional reimbursement for innovative treatments must be weighed against the overall budgetary constraints of CMS. The timeline of implementation following the establishment of a new HCPCS Level II code is important for CorMedix to capitalize on its investment and for stakeholders to gauge the financial viability of DefenCath's use in outpatient settings.
BERKELEY HEIGHTS, N.J., April 15, 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 DefenCath® (taurolidine and heparin) catheter lock solution (CLS) is now commercially available for U.S. inpatient use.
DefenCath (taurolidine and heparin) is approved by the U.S. Food and Drug Administration (FDA) to reduce the incidence of catheter-related bloodstream infections (CRBSIs) in adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter (HD-CVC).
Joseph Todisco, Chief Executive Officer of CorMedix commented, “Today opens a new chapter for healthcare providers, offering them an opportunity to reduce the risk of CRBSIs in a patient population already vulnerable due to underlying kidney failure. We are proud to provide an option for adult patients who face the risk of CRBSIs. We look forward to expanding the availability of DefenCath to the outpatient setting later this year.”
The commencement of U.S. outpatient commercialization of DefenCath is planned for July 1, 2024. Outpatient commercial availability is contingent upon the Center for Medicare & Medicaid Services (CMS) approval and implementation of the DefenCath Transitional Drug Add-On Payment Adjustment (TDAPA) application in accordance with the agency’s publicly stated objective that CMS aims for an effective date for applying the TDAPA for a particular product that is one quarter after the effective date of the HCPCS code for the product. The CMS Final HCPCS coding decision for DefenCath was published by CMS on April 2nd, establishing a new HCPCS Level II code for DefenCath, and CorMedix continues to work closely with CMS on the TDAPA implementation process.
To learn more about DefenCath, visit DefenCath.com.
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, pending a timely implementation of TDAPA. 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:
Dan Ferry
Managing Director
LifeSci Advisors
(617) 430-7576
FAQ
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