The US Food & Drug Administration (FDA) today approved  Novartis' product Exjade in the treatment of iron overload in non-transfusion dependant thalassemia (NTDT). The value of FerriScan, used in studies to select patients for therapy and to manage therapy, and has earned it FDA marketing approval as a companion diagnostic for Exjade for this indication.FerriScan offers a safe and accurate measurement of liver iron concentration (LIC) regarded by the FDA as necessary for Exjade's safe and effective use.

"The FerriScan device is a non-invasive test that helps physicians to select appropriate patients 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., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health.

Link to FDA Media release

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