– CorMedix to advocate for patient safety and infection prevention as part of
Leapfrog’s Partners Advisory Committee
BERKELEY HEIGHTS, N.J., Dec. 04, 2023 (GLOBE NEWSWIRE) — 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 an agreement with The Leapfrog Group, an independent national watchdog organization of employers and other purchasers focused on health care safety, whereby CorMedix Inc. will become a member of the Leapfrog Partners Advisory Committee.
The Partners Advisory Committee is a platform for the creation, implementation and evaluation of initiatives that advance the Leapfrog and organizations’ alike mission for patient safety and promote a shared accountability for patient safety and well-being. As a Leapfrog partner, CorMedix will advise the Leapfrog board and management on industry and policy trends and help shape the organization’s long-term strategic vision.
“An alliance between The Leapfrog Group and CorMedix brings together two organizations both focused on a common goal: improving patient safety and quality of care across the U.S. healthcare system,” said Joseph Todisco, Chief Executive Officer, CorMedix. “CorMedix is dedicated to developing solutions that reduce the risk of healthcare associated infections, in particular catheter-related bloodstream infections (CRBSIs). About 250,000 CRBSIs occur annually among U.S. patients with an intravascular device, and one in four patients who acquire these infections die. It is important we all come together and advocate for patients who suffer from these preventable infections, in addition to managing their already challenging health conditions.”
“We are proud to join with CorMedix to improve patient safety in the United States. We need their insights and expertise more than ever. Every American deserves the highest quality health care, and together with CorMedix we can achieve our shared vision for excellence,” said Leah Binder, Leapfrog president and CEO.
In November, CorMedix announced that the U.S. Food and Drug Administration (FDA) approved DefenCath® (taurolidine and heparin) catheter lock solution (CLS) to reduce the incidence of CRBSIs for the limited population of adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter. DefenCath is the first and only FDA-approved antimicrobial CLS in the U.S. and was shown to reduce the risk of catheter related bloodstream infections (CRBSIs) by up to 71% in a Phase 3 clinical study.
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.
See full prescribing information for additional details on safety and risks associated with DefenCath.
