International Approvals: Benephit, AlzheimAlert, MAA Kit

Yael Waknine

March 01, 2005

March 1, 2005 — The European Commission has approved for use in the European Union a catheter system for direct infusion of medications and other therapeutic agents to the kidneys via the renal arteries, and a neural thread protein urine immunoassay to aid in the diagnosis of Alzheimer's disease. The Dutch Regulatory Agency has approved a preparation kit for technetium Tc 99m albumin aggregated injection for use in lung imaging.

Catheter System (Benephit) for Targeted Renal Therapy Approved in EU

On Feb. 17, the European Commission approved for use in the European Union a catheter system (Benephit Infusion System, made by FlowMedica, Inc.) for direct renal infusion of medications and other therapeutic agents.

The system consists of a bifurcated infusion catheter with introduction sheath that allows infusion of therapeutic agents into both renal arteries simultaneously, while enabling concurrent cardiovascular procedures through a single-vessel access site in the femoral artery.

The catheter system is intended for use as an alternative to standard intravenous (IV) infusion for delivery of medications to treat kidney dysfunction related to cardiovascular disease.

The device is being evaluated for use in patients who could benefit from minimally invasive cardiovascular procedures and diagnostic tests (stent placement, angioplasty, or angiography) but may be at risk for acute kidney failure due to radiocontrast nephropathy (RCN).

Results of a randomized clinical trial have shown that use of the device for intrarenal medication delivery significantly improves kidney function while reducing medication blood levels and adverse events in patients at risk for RCN compared with IV administration.

The device is also being evaluated as a method of delivering medications and other therapeutic agents to patients with congestive heart failure who have developed cardiorenal syndrome that is characterized by edema, resistance to conventional therapy, deteriorating kidney function, and increased mortality.

The catheter system was approved by the FDA in January 2004 for use in the U.S.

Immunoassay for Alzheimer's NTP Biomarker (AlzheimAlert) Approved in EU

On Nov. 8, 2004, the European Commission approved for use in the European Union a urine neural thread protein (NTP) biomarker test kit (AlzheimAlert, made by Nymox Pharmaceutical Corp.) for use as an aid in the clinical diagnosis of Alzheimer's disease (AD).

The test is a competitive immunoassay that measures NTP levels in urine. According to a company news release, NTP has also been identified in brain tissue and cerebrospinal fluid, and there is evidence that the protein is involved in the neuronal cell death and neuritic sprouting that are characteristic of AD.

Elevation of NTP levels occurs early in AD and is positively correlated with the severity of dementia; readings of greater than 18 are considered abnormal and are closely associated with AD and cognitive decline.

The approval was based on the results of clinical studies showing that the biomarker test has a sensitivity of greater than 80% and a specificity of 90% for AD.

The assay is currently under review by the FDA for approval in the U.S.

Technetium Lung Imaging Agent Kit (MAA) Approved in Netherlands

On Feb. 16, the Dutch regulatory agency approved for use in the Netherlands a preparation kit for technetium Tc 99m albumin aggregated injection (MAA kit, made by Draximage, a division of Draxis Health, Inc.). The lung imaging agent is indicated for use in the evaluation of pulmonary perfusion in adult and pediatric patients, and to aid in the evaluation of peritoneovenous (LeVeen) shunt patency in adults.

The kit includes a lyophilized formulation of aggregated albumin that is labeled with the short-lived isotope technetium Tc 99m immediately prior to use.

Approval of the imaging agent kit in the Netherlands allows the company to initiate the mutual recognition procedure for its approval in other member states of the European Union.

The kit was approved for use in the U.S. by the FDA in 1987; similar kits marketed by other companies are also available.

Reviewed by Gary D. Vogin, MD


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