The U.S. Food and Drug Administration recently announced the authorization of FerriScan® R2-MRI to be marketed as an imaging companion diagnostic device for the safe and effective use of Exjade in patients with non-transfusion-dependent thalassemia. Exjade® (deferasirox) is a drug marketed by Novartis to remove excess iron in patients with genetic blood disorders.
In 2005 FerriScan gained FDA marketing clearance for measuring liver iron concentration (LIC). "The FerriScan device is a non-invasive test that helps physicians to select appropriate patients [with NTDT] for Exjade therapy as well as monitor their response to the drug, and discontinue therapy when LIC reaches safe levels," said Alberto Gutierrez, Ph.D., of the Office of In-Vitro Diagnostic and Radiological Health at the FDA.
According to the National Heart, Lung and Blood Institute, Thalassemia conditions can cause the body to make fewer healthy red blood cells and less hemoglobin, a protein required for transportation of oxygen and carbon dioxide throughout the body. Some thalassemia patients require frequent red blood cell transfusions to maintain an acceptable level of hemoglobin and iron overload is common in these patients. NTDT patients are genetically pre-disposed to iron overload even in the absence of regular blood transfusions.
FerriScan has been used extensively in pharmaceutical companies' clinical trials of drugs for the treatment of chronic iron overload since 2004. This FDA announcement recognizes FerriScan's important role in patient management. The FDA's granting of the de novo request was based largely on data from Exjade clinical studies that used FerriScan LIC results as the primary outcome measure. An additional 230-patient study found that FerriScan results were as accurate as liver biopsy for measuring LIC.
FerriScan is used in many hospitals around the world, including over 40 MRI Centers in the U.S. This authorization will assist U.S. physicians in gaining access to FerriScan for identification and management of patients with iron overload disorders.