FDA Approves AdReview™ Mortality Risk Indicator

In short

GE Healthcare has gained FDA approval of a new indication for AdreView™ (Iobenguane I 123 Injection). This is the first and only FDA approved molecular imaging agent to link nerve function in the heart to a patient’s mortality risk.

Background

Being device guys we’re not frequent visitors to the world of pharmaceuticals, but we deal on a frequent basis with devices intended to treat cardiac nerve activity, so we’ll break the rules. AdreView is a radiopharmaceutical indicated for use in a variety of diagnostic tests. Now the FDa has added to the list the scintigraphic imaging assessment of sympathetic innervation of the myocardium. The aim is to assist in the evaluation of adult patients with NYHA class II or class III heart failure and left ventricular ejection fraction of 35% to help identify patients with one and two-year mortality risks as indicated by an H/M ratio = 1.6.

Increased myocardial sympathetic activity is a prominent feature of heart failure and is often associated with decline in left ventricular function, worsening heart failure symptoms, and sudden cardiac death. This increase leads to a depletion of norepinephrine (NE) storage and uptake. AdreView provides a means for assessing the neuronal capacity for uptake and storage of NE. While current prognostic tests look at the effect of the disease on heart muscle and blood flow, imaging with AdreView uses the heart to mediastinum (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 heart compared to that of a reference region in the mediastinum. This measurement has a typical range of 1-2.4 and can accurately identify 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 with a 99% probability of survival at one year (negative predictive value, NPV). In patients with congestive heart failure, AdreView utility has not been established for selecting therapy, monitoring response to therapy, or to identify a patient with a high risk for death.

Physician comments

“Predicting disease progression in heart failure patients can be difficult, and there are currently a limited number of prognostic tools available to help clinicians understand the likelihood for heart failure progression,” said James Arrighi, MD, Associate Professor of Medicine, Brown University, Providence, RI and current president of the American Society of Nuclear Cardiology. “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.”

Company comments

“GE Healthcare is committed to providing innovative and effective medical products that will aid physicians in determining mortality risk in patients with cardiovascular disease, and we are pleased that the FDA has approved AdreView for this indication in heart failure patients,” said Terri Moench, General Manager, SPECT, GE Healthcare Medical Diagnostics. “The use of imaging tests is consistent with current trends towards gaining improved and earlier understanding of heart disease at a molecular level and may enable providers to help deliver better care to more people.”

Full release including references here.

Source: G E Healthcare, Business Wire