GE Healthcare's AdreView Wins Approval for New Indication

GE Healthcare today announced the U.S. Food and Drug Administration (FDA)approval of a new indication for AdreView™ (Iobenguane I 123 Injection), thefirst and only FDA approved molecular imaging agent to link nerve function inthe heart to a patient's mortality risk.^1 AdreView is approved for thescintigraphic assessment of myocardial sympathetic innervation (cardiac nerveactivity) to assist in the evaluation of patients with New York HeartAssociation (NYHA) Class II or Class III heart failure and left ventricularejection fraction (LVEF) ≤ 35%.^2“Predicting disease progression in heart failure patients can be difficult,and there are currently a limited number of prognostic tools available to helpclinicians understand the likelihood for heart failure progression,” saidJames Arrighi, MD, Associate Professor of Medicine, Brown University,Providence, RI and current president of the American Society of NuclearCardiology. “Now, with AdreView, we have a tool that will provide clinicianswith a numeric score to help stratify mortality risk, and may help to promotemore informed clinical decision-making.”Increased myocardial sympathetic activity is a prominent feature of heartfailure^3 and is often associated with decline in left ventricular function,worsening heart failure symptoms, and sudden cardiac death.^1,4 This increaseleads to a depletion of norepinephrine (NE) storage and uptake.^5 AdreViewprovides a means for assessing the neuronal capacity for uptake and storage ofNE.^2 While current prognostic tests look at the effect of the disease onheart muscle and blood flow, imaging with AdreView uses the heart tomediastinum (H/M) ratio to assess the functionality of the sympathetic nerves.With AdreView, the H/M ratio is a measure of radioactivity uptake in the heartcompared to that of a reference region in the mediastinum (the mass of tissuesand organs between the two pleural sacs that separate the heart from thelungs).^2,6 This measurement has a typical range of 1-2.4 and can accuratelyidentify patients with lower than average one- and two- year mortality risk.In clinical studies, an AdreView Score (H/M ratio) of ≥1.6 was associated witha 99% probability of survival at one year (negative predictive value, NPV).^2In patients with congestive heart failure, AdreView utility has not beenestablished for selecting therapy, monitoring response to therapy, or toidentify a patient with a high risk for death.^2