GE Healthcare announced that the FDA has approved a new indication for AdreView (lobenguane I 123 Injection), the first and only FDA approved molecular imaging agent to link nerve function in the heart to a patient’s mortality risk. AdreView is approved for the scintigraphic assessment of myocardial sympathetic innervation (cardiac nerve activity) to assist in the evaluation of patients with New York Heart Association (NYHA) Class II or Class III heart failure and left ventricular ejection fraction (LVEF) ≤ 35%.
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. The H/M ratio in AdreView 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 two open-label, multicenter, international trials, the safety and efficacy of AdreView was evaluated in 985 patients with NYHA Class II or Class III heart failure with LVEF ≤35%. A total of 110 patients without a history of heart disease also received a single dose of AdreView. The primary endpoint for analysis was all-cause mortality. By 12 months following enrollment among the 964 heart failure patients in the efficacy population, 50 (5%) patients had died, 61 (6%) had missing follow-up information and three patients had missing H/M ratios. One-year mortality rates in relation to AdreView H/M ratio were : <1.2: 13.4%; 1.2–1.6: 5.5%; ≥1.6: 1%. By 23 months following enrollment (the requirement for designation of two-year follow-up), 96 (10%) patients had died, 201 (21%) patients had missing follow-up information and three patients were missing H/M ratio data. Two-year mortality rates in relation to AdreView H/M ratio were : <1.2: 22%; 1.2–1.6: 11.5%; ≥1.6: 3.3%
AdreView is already approved for the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests.
For more information visit http://newsroom.gehealthcare.com/.