FDA Approves AdreView
FDA Approves GE Healthcare's AdreView (Iobenguane I 123 Injection) Diagnostic Agent for Detecting Neuroendocrine Tumors in Children, Adults
PRINCETON, N.J.--(BUSINESS WIRE)--Sep 19, 2008 - GE Healthcare, a unit of General Electric Company (NYSE:GE), today announced that the Food and Drug Administration (FDA) has approved AdreView (Iobenguane I 123 Injection), a molecular imaging agent for the detection of rare neuroendocrine tumors in children and adults. AdreView provides high quality images that allow physicians to detect tumors, both at the time of initial diagnosis and at later examinations when relapse or recurrence is suspected.
"AdreView will have an immediate impact on improving diagnostic assessment of pediatric cancer patients with neuroblastoma," said Dr. Arnold Jacobson, MD, PhD, GE's clinical project leader for the AdreView program. "AdreView also will provide reliable imaging data to aid in identifying primary and metastatic pheochromocytoma, a predominantly adult tumor that often presents diagnostic challenges for clinicians. The introduction of AdreView is a reflection of our commitment to provide new and improved molecular imaging solutions for physicians and their patients."
Neuroblastoma is the most common extra-cranial solid tumor of young children up to 5 years of age, while pheochromocytoma is a rare tumor typically affecting adults. Both tumors usually arise from tissues of the sympathetic nervous system, most commonly in the adrenal glands. Neuroblastoma and pheochromocytoma can be difficult to detect at an early stage because symptoms may be non-specific when the tumors are small. AdreView images reflect the functional behavior of the tumor cells, thus allowing clearer characterization of even small tumors in comparison to similar appearing but non-malignant tissues. AdreView provides valuable adjunctive information to complement anatomic imaging procedures such as CT and MRI.
GE Healthcare expects to begin supplying this important new imaging agent to hospitals and imaging centers throughout the United States in the coming weeks. It will mark the first time this imaging agent, manufactured to the high standards required by FDA, is available throughout the country. AdreView will also permit imaging of these tumors with a lower radiation dose than other agents that have been available for this purpose. AdreView also can be used with Single Photon Emission Computed Tomography (SPECT) imaging, a valuable addition for localizing sites of disease in the body.
"AdreView is just the first of many new products we are developing to deliver on the promise of molecular medicine," said Don Black, MD, vice-president of research and development for GE Healthcare's Medical Diagnostics business. "We are invested in making imaging agents that will make new medical breakthroughs a reality."
GE Healthcare began developing AdreView in 2004, and the agent was granted orphan-drug status by the FDA in December 2006. In May 2008, AdreView received priority review status from the FDA.
Important Safety Information
AdreView contains benzyl alcohol (10.3 mg/mL) which may cause serious reactions in premature or low birth-weight infants. Benzyl alcohol has been associated with a fatal "Gasping Syndrome" in premature infants and infants of low birth weight. Have anaphylactic and hypersensitivity treatment measures available prior to AdreView administration. AdreView is cleared by glomerular filtration and is not dialyzable. The radiation dose to patients with severe renal impairment may be increased due to the delayed elimination of the drug. AdreView is contraindicated in patients with known hypersensitivity to Iobenguane or Iobenguane sulfate. In clinical trials the most common adverse reactions seen were dizziness, rash, puritis, flushing or injection site hemorrhage reported in less than 1% of patients.
Please see full prescribing information www.md.gehealthcare.com
About GE Healthcare
GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery, and biopharmaceutical manufacturing technologies is helping clinicians around the world re-imagine new ways to predict, diagnose, inform, treat and monitor disease, so patients can live their lives to the fullest.
GE Healthcare's broad range of products and services enable healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases and other conditions earlier. Our vision for the future is to enable a new "early health" model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention. Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our website at www.gehealthcare.com.
Posted: September 2008