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CORRECTING and REPLACING FDA Approves GE Healthcare's AdreView™ (Iobenguane I 123 Injection) for Cardiac Risk Evaluation in Heart Failure Patients

2013-03-22 19:07 ET - News Release

AdreView is the First and Only Imaging Agent Approved for Visualization of Myocardial Sympathetic Innervation in Certain Heart Failure Patients


Company Website: http://www.gehealthcare.com
PRINCETON, N.J. -- (Business Wire)

The first paragraph has been replaced.

The corrected release reads:

FDA Approves GE Healthcare's AdreView™ (Iobenguane I 123 Injection) for Cardiac Risk Evaluation in Heart Failure Patients

AdreView is the First and Only Imaging Agent Approved for Visualization of Myocardial Sympathetic Innervation in Certain Heart Failure Patients

GE Healthcare today announced the U.S. Food and Drug Administration (FDA) approval of a new indication for AdreView™ (Iobenguane 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.1 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% to help identify patients with one and two-year mortality risks as indicated by an H/M ratio ≥1.6. In patients with congestive heart failure (CHF), utility has not been established for selecting therapy, monitoring response to therapy, or to identify a patient with high risk of death.2

“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.”

Increased myocardial sympathetic activity is a prominent feature of heart failure3 and is often associated with decline in left ventricular function, worsening heart failure symptoms, and sudden cardiac death.1,4 This increase leads to a depletion of norepinephrine (NE) storage and uptake.5 AdreView provides a means for assessing the neuronal capacity for uptake and storage of NE.2 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 (the mass of tissues and organs between the two pleural sacs that separate the heart from the lungs).2,6 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).2

“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.”

The safety and efficacy of AdreView were evaluated in two open-label, multicenter, international trials 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 endpoint for analysis was all-cause mortality, an outcome confirmed by review of an independent adjudication committee. 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: 1.0%. 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: 22.0%; 1.2-1.6: 11.5%; ≥1.6: 3.3%.2

About Heart Failure

Heart failure is a chronic, progressive condition in which the heart muscle is unable to pump enough blood through the heart to meet the body's needs.7 Nearly 5.1 million Americans suffer from heart failure, and half of these individuals will die within five years.8 The total cost of heart failure is estimated to be nearly 32 billion to the US health system.8 Patients who have previously suffered from heart failure have a sudden death rate that is six to nine times greater than the general population.9

Important Risk and Safety Information about AdreView (Iobenguane I 123 Injection)

INDICATIONS: AdreView is a radiopharmaceutical indicated for: (1) use in the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests; and, (2) scintigraphic imaging assessment of sympathetic innervation of the myocardium to assist in the evaluation of adult patients with NYHA class II or class III heart failure and left ventricular ejection fraction ≤35% to help identify patients with one and two-year mortality risks as indicated by an H/M ratio ≥ 1.6. In patients with congestive heart failure (CHF), utility has not been established for selecting therapy, monitoring response to therapy, or to identify a patient with high risk of death. CONTRAINDICATIONS: AdreView is contraindicated in patients with known hypersensitivity to iobenguane or iobenguane sulfate. WARNINGS AND PRECAUTIONS:Hypersensitivity Reactions: Hypersensitivity reactions have followed AdreView administration. Have anaphylactic and hypersensitivity treatment measures available prior to administration. Benzyl Alcohol Toxicity in Infants: AdreView contains benzyl alcohol, which may cause serious reactions, in premature or low birth-weight infants. Patients with Severe Renal Impairment: As AdreView is cleared by glomerular filtration and is not dialyzable, these patients may have increased radiation exposure and decreased image quality. Thyroid Accumulation: Administer thyroid blockade to patients at risk of thyroid accumulation of AdreView. Medication Withdrawal: Drugs that block norepinephrine uptake or deplete norepinephrine stores, such as some antihypertensive agents, may decrease AdreView uptake and may lead to incorrect imaging results. When medically feasible, stop these drugs before AdreView administration. Hypertension: AdreView may increase release of norepinephrine from chromaffin granules producing transient hypertension. Individuals with Neurological Diseases that Affect the Sympathetic Nervous System: Imaging in these patients may show decreased cardiac uptake independent of heart disease. ADVERSE REACTIONS: Serious hypersensitivity reactions have been reported following AdreView administration. The most common adverse reactions in NDA clinical trials - dizziness, rash, pruritis, flushing, headache and injection site reactions - occurred in ≤ 1.3% of patients. USE IN SPECIFIC POPULATIONS:Pregnancy: Radiopharmaceuticals have potential to cause fetal harm. It is not known whether AdreView can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. AdreView should be given to a pregnant woman only if clearly needed. Nursing Mothers: It is not known whether AdreView is excreted into human milk, however, iodine 123 is excreted into human milk. A decision should be made whether to interrupt nursing after administration of AdreView or not to administer AdreView. Pediatric Use: Safety and effectiveness have not been established in pediatric patients < 1 month of age or in any pediatric patients with CHF. Geriatric Use: Clinical experience has not identified differences in responses between the elderly and younger patients. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and image interpretation. Consider assessment of renal function in elderly patients prior to AdreView administration.

Prior to AdreView administration, please read the Full Prescribing Information

About GE Healthcare

GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE (NYSE: GE) works on things that matter - great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients.

For our latest news, please visit http://newsroom.gehealthcare.com

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1 Jacobson AF, Senior R, Cerqueira MD, et al. Myocardial iodine-123 meta-iodobenzylguanidine imaging and cardiac events in heart failure: results of the prospective ADMIRE-HF (AdreView Myocardial Imaging for Risk Evaluation in Heart Failure) Study. J Am Coll Cardiol. 2010;55:2212-2221

2 AdreView Prescribing Information, GE Healthcare. 2013.

3 Leimbach WN Jr., Wallin BG, Victor RG, Aylward PE, Sundlof G, Mark AL. Direct evidence from intraneural recordings for increased central sympathetic outflow in patients with heart failure. Circulation 1986;73:913–9.

4 Brunner-La Rocca HP, Esler MD, Jennings GL, Kay DM. Effect of cardiac nervous activity on mode of death in congestive heart failure. Eur Heart J 2001;22:1136–43.

5 Eisenhafer G, Friberg P, Rundqvist B, et al. Cardiac sympathetic nerve function in congestive heart failure. Circulation. 1996;93:1667-1676.

6 The American Heritage Medical Dictionary. http://medical-dictionary.thefreedictionary.com/mediastinum. Accessed March 2013.

7 Hall MJ, Levant S, DeFrances C. Hospitalization for Congestive Heart Failure: United States, 2000-2010. US Department of Health and Human Services. Centers for Disease Control and Prevention. 2012.

8 Go AS, Mozaffarian D, Roger VL, et al. Heart disease and stroke statistics—2013 update: a report from the American Heart Association. Circulation.2013;127:e6-e245.

9 National Heart, Lung, and Blood Institute. Congestive Heart Failure: A New Epidemic in the United States. Data Fact Sheet. September 1996

 

Contacts:

GE Healthcare
Scott Lerman
609-514-6346 (office)
609-937-9253 (mobile)
scott.lerman@ge.com

Source: GE Healthcare

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