FDA approves imaging agent for heart failure

Twitter icon
Facebook icon
LinkedIn icon
e-mail icon
Google icon

The FDA has approved a new indication for Iobenguane I 123 Injection for the scintigraphic assessment of myocardial sympathetic innervation to assist in the evaluation of patients with heart failure and left ventricular ejection fraction of 35 percent or less.

AdreView (GE Healthcare) is a molecular imaging agent that can be used to assess nerve function in the heart to a patient’s mortality risk. Increased myocardial sympathetic activity is a prominent feature of heart failure and is often associated with decline in left ventricular function, worsening heart failure symptom and sudden cardiac death. This increase leads to a depletion of norepinephrine (NE) storage and uptake, according to Princeton, N.J.-based GE Healthcare.

AdreView provides a means for assessing the neuronal capacity for uptake and storage of NE. AdreView uses the heart to mediastinum (H/M) ratio to assess the functionality of the sympathetic nerves. The safety and efficacy of AdreView were evaluated in two open-label, multicenter, international trials.

AdreView is indicated for use in the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests, and for scintigraphic imaging assessment of sympathetic innervation of the myocardium to assist in the evaluation of adult patients with New York Heart Association class II or class III heart failure with left ventricular ejection fraction of 35 percent or less to help identify patients with one and two-year mortality risks as indicated by an H/M ratio of 1.6 or less. 

In patients with congestive heart failure, utility has not been established for selecting therapy, monitoring response to therapy, or to identify a patient with high risk of death.