Full Press Release Details
INC. ANNOUNCES FDA APProval of Defencath To reduce
the incidence of catheter-related bloodstream infections in
- First and only FDA-approved
antimicrobial catheter lock solution in the U.S.
- Company expects DefenCath
to be available in Q1 2024 in the inpatient setting
NJ - November 15, 2023 - CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing
therapeutic products for the prevention and treatment of life-threatening diseases and conditions, today announced that the U.S. Food
and Drug Administration (FDA) has approved DefenCath (taurolidine and heparin) catheter lock solution (CLS) to reduce the incidence
of catheter-related bloodstream infections (CRBSIs) for the limited population of adult patients with kidney failure receiving chronic
hemodialysis through a central venous catheter (CVC). DefenCath is the first and only FDA-approved antimicrobial CLS in the U.S. and was
shown to reduce the risk of CRBSIs by up to 71% in a Phase 3 clinical study.
Joseph Todisco, Chief Executive Officer of CorMedix
commented, "The approval of DefenCath marks a major advancement in reducing life-threatening infections for patients receiving hemodialysis
via central venous catheters and an important milestone for CorMedix. As the first FDA-approved antimicrobial catheter lock solution designed
to prevent CRBSIs, DefenCath offers healthcare providers an option to reduce the risk of infections in a patient population already vulnerable
due to underlying kidney failure. We thank all the patients, caregivers, clinical investigators, and our employees who have played an
integral role in the development and regulatory approval of DefenCath. Our commercial team along with our broader organization is preparing
for commercial launch, and we look forward to working with healthcare providers and facilities to give hemodialysis patients access to
DefenCath in early 2024."
The FDA approval of DefenCath was supported by
results from the randomized, double-blind, active control, multicenter pivotal Phase 3 LOCK-IT-100 clinical trial designed to assess the
efficacy and safety of DefenCath for reducing the incidence of CRBSIs in patients with kidney failure receiving chronic hemodialysis.
In the study, a total of 806 subjects were randomized to receive either DefenCath or heparin as a CLS. Patients in the DefenCath group
had a lower incidence of CRBSI events compared to patients in the control group. The Hazard Ratio was 0.29, corresponding to a statistically
significant 71% reduction in risk of developing a CRBSI. An independent Data Safety and Monitoring Board recommended an early termination
of the study based on demonstrated efficacy and a pre-specified level of statistical significance with no safety concerns. Adverse events
were comparable to control.
Edward V. Hickey, III, President of the American
Association of Kidney Patients and Chair of the Veterans Health Initiative stated, "Patients and their loved ones have faced many
burdens related to kidney failure, including complications caused by catheter related bloodstream infections and associated loss of work,
severe disability and death. Until now, patients who need hemodialysis via a central venous catheter have had little choice other than
to accept high infection risks associated with the existing standard of care. The FDA's approval of DefenCath is a meaningful moment
for patients and their healthcare providers because they now have a new alternative to reduce the risks of CRBSIs." Mr. Hickey is
a kidney patient, former senior staff member of the U.S. Congress and has served in two presidential administrations.
About Catheter-Related Bloodstream Infections
Catheter-related bloodstream infections (CRBSIs)
are common in patients with central venous catheters (CVCs). Approximately 80% of patients starting hemodialysis will have a CVC inserted
for vascular access. CRBSI's can occur in up to a third of HD-CVC patients and over 50% of CRBSIs occur within the first 3 months
following CVC insertion. Each year, ~250,000 CRBSIs occur in patients with an intravascular device, such as central venous catheters (CVCs),
leading to death in about one in four patients infected. CRBSIs can lead to more hospital admissions, longer stays, and long-term complications
such as cardiovascular events. CRBSIs in hemodialysis are caused by a wide range of pathogens, many of which are antibiotic-resistant.
About DefenCath (taurolidine
and heparin) Catheter Lock Solution
DefenCath is an antimicrobial catheter lock solution
(CLS) approved by the FDA to reduce the incidence of catheter-related bloodstream infections (CRBSIs) for the limited population of adult
patients with kidney failure receiving chronic hemodialysis through a central venous catheter (CVC). It is comprised of the anticoagulant
heparin and taurolidine, a broad-spectrum non-antibiotic antimicrobial and antifungal agent. DefenCath is designed to occupy the catheter
lumen in between sessions of dialysis. Microbial resistance to taurolidine has not been documented in the laboratory or in clinical use
in Europe, likely due to the chemical mechanism of action.
Indication and Important Safety Information for DefenCath
DefenCath was approved pursuant to the limited
population for antibacterial and antifungal drugs (LPAD) pathway established by the 21st Century Cures Act to address unmet needs of patients
with serious bacterial and fungal infections. In addition, FDA designated DefenCath as a Qualified Infectious Disease Product (QIDP) established
by the Generating Antibiotic Incentives Now (GAIN) Act that supports development of antibacterial and antifungal products that treat serious
or life-threatening infections. FDA approved DefenCath to reduce the incidence of catheter-related bloodstream infections in adult patients
with kidney failure receiving chronic hemodialysis through a central venous catheter. It is indicated for use in a limited and specific
population of patients. The safety and effectiveness of DefenCath have not been established for use in populations other than adult patients
with kidney failure receiving chronic HD through a CVC.
DefenCath contains taurolidine, a thiadiazinane
antimicrobial and heparin, an anticoagulant, which can induce thrombocytopenia or HIT, and is contraindicated and should not be used in
patients with known HIT or hypersensitivity to taurolidine, heparin or citrate. It is not intended for systemic administration. DefenCath
must be aspirated from the catheter and discarded prior to the initiation of the next hemodialysis session.
The mean age of patients in LOCK-IT-100 was 61
years, 58% of patients identified as male, 42% identified as female, 63% as white and 30% as black or African-American. Patients with
diabetes at baseline accounted for 70% of patients and the mean body mass index was 30. The majority of patients had been receiving hemodialysis
for 12 months or fewer. The location of the CVC was the jugular vein in 92% of patients.
The most frequently reported adverse reactions
occurring in 2% of patients in LOCK-IT-100 using DefenCath as a catheter lock solution were hemodialysis catheter malfunction, hemorrhage/bleeding,
nausea, vomiting, dizziness, musculoskeletal chest pain, and thrombocytopenia. Adverse reactions leading to death occurred in 5% (18/398)
of patients in the DefenCath arm and 5% (21/399) in the heparin arm. Adverse reactions leading to discontinuation of study drug occurred
in 17% (69/398) in the DefenCath arm and 18% (72/399) in the heparin arm.
The safety and effectiveness of DefenCath have
not been established for use in populations other than adult patients with kidney failure receiving chronic hemodialysis through a CVC.
DefenCath is not intended for systemic administration and therefore maternal use is not expected to result in fetal exposure to the drug
and breast feeding is not expected to result in exposure of the infant. No animal reproduction study was conducted with DefenCath. The
safety and effectiveness of DefenCath have not been established in pediatric patients. No overall differences in safety or effectiveness
were observed between patients 65 years of age and older and younger adult patients.
FDA approves new drug under special pathway for patients receiving
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 developing its lead product DefenCath , a novel, non-antibiotic antimicrobial solution designed
to prevent costly and life-threatening bloodstream infections associated with the use of central venous catheters in patients undergoing
chronic hemodialysis. DefenCath has been designated by FDA as Fast Track and as a Qualified Infectious Disease Product (QIDP), and the
original New Drug Application (NDA) received priority review in recognition of its potential to address an unmet medical need. DefenCath
was approved by the FDA on November 15, 2023 and the Company has indicated an estimated initial launch in 1Q 2024. CorMedix also intends
to develop DefenCath as a catheter lock solution for use in other patient populations, and the Company is working with top-tier researchers
to develop taurolidine-based therapies for rare pediatric cancers. 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. All statements,
other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or CorMedix's prospects,
including, but not limited to, CorMedix's future financial position, financing plans, future revenues, projected costs and the sufficiency
of our cash and short-term investments to fund our operations 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, including: the risks and uncertainties
related to market conditions; CorMedix's ability to manage its cash resources and the impact on current, planned or future research;
and the ability to achieve commercial launch in Q1 2024. These and other risks are described in greater detail in CorMedix's filings
with the SEC, 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 investors should not place undue reliance