PRINCETON, NJ — Almost four years after the company submitted its application to the FDA, GE Healthcare has announced approval of an expanded indication for its iobenguane I 123 injection (AdreView) scintigraphic imaging agent.
Functioning molecularly as a norepinephrine analog, the radionuclide tracer can show relative levels of norepinephrine uptake in the cardiac sympathetic nervous system and thereby contribute to risk stratification in patients with heart failure. In general, prognosis in heart failure is worse with greater neuronal release of norepinephrine and better with improved reuptake of the neurotransmitter.
The new approval of AdreView, known molecularly as 123I meta-iodobenzylguanidine (123I mIBG), was for assessment of myocardial sympathetic innervation in evaluation of patients with NYHA class 2–3 heart failure with an LVEF <35%, according to GE Healthcare's announcement today. Its relative scintigraphic uptake in the heart compared with a reference region in the mediastinum (H/M ratio) "can accurately identify patients with lower-than-average one- and two-year mortality risk," according to the company.
In the observational ADMIRE-HF trial, as reported by heartwire , 25% of the 961 patients with systolic heart failure undergoing 123I-mIBG scintigraphy experienced a primary event (NYHA class progression, potentially life-threatening arrhythmic event, or cardiac death). The two-year event rate was 15% for those who had an H/M ratio >1.60 vs 37% for those with an H/M ratio <160, for a hazard ratio of 0.40 (p<0.001).
GE Healthcare's statement quotes American Society of Nuclear Cardiology president Dr James A Arrighi (Brown University, Providence, RI): "There are currently a limited number of prognostic tools available to help clinicians understand the likelihood for heart-failure progression. . . . Now, with AdreView, we have a tool that will provide clinicians with a numeric score to help stratify mortality risk and may help to promote more informed clinical decision-making."
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Cite this: FDA Approves Heart Sympathetic Activity Imaging Agent for HF Evaluation - Medscape - Mar 22, 2013.