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FDA Approves Use of Bracco Diagnostics Inc.'s MultiHance Injection in MRA


7/30/2012 7:48:17 AM

PRINCETON, N.J.--(BUSINESS WIRE)-- Bracco Diagnostics Inc., the US-based company of the Bracco Group – one of the world’s leading companies in the diagnostic imaging business – today announced that the U.S. Food and Drug Administration (FDA) has approved the use of MultiHance® (gadobenate dimeglumine) Injection, 529 mg/mL, in magnetic resonance angiography (MRA) to evaluate adults with known or suspected renal or aorto-ilio-femoral occlusive vascular disease. MultiHance was already the highest relaxivity gadolinium-based contrast agent (GBCA) available for intravenous use in magnetic resonance imaging (MRI) of the central nervous system (CNS) in adults and pediatric patients. The recommended dose for both MRI of the CNS and MRA examinations is 0.1 mmol/kg (0.2 mL/kg) of MultiHance.

The approval of MultiHance in MRA was granted based on data submitted to the FDA that included safety and efficacy results from two large, prospective, multi-center clinical trials (one for each arterial vascular territory: renal and aorto-ilio-femoral). Assessment of diagnostic efficacy for detecting/excluding clinically significant steno-occlusive disease (= 51% stenosis) was based on comparisons of sensitivity and specificity between MultiHance MRA and non-contrast MRA, with DSA as the standard of truth. Results of both trials showed a statistically significant increase in both sensitivity and specificity of MultiHance-enhanced MRA over non-contrast MRA in detecting clinically significant steno-occlusive disease.

“MultiHance has long been distinguished in the MRI of the CNS as a gadolinium-based contrast agent characterized by a strong increase in relaxivity in any medium containing serum proteins, contributing to increased contrast-to-noise ratio and lesion-to-brain ratio and improved visualization. It also counts a strong record of safety that spans over 14 million administered doses,” said Dr. Alberto Spinazzi, Senior Vice President, Group Medical and Regulatory Affairs at Bracco Diagnostics Inc. “The approval of MultiHance for use in MRA of renal and runoff arteries delivers to the radiologist a powerful tool, bringing the power of high relaxivity to the assessment and diagnosis of debilitating vascular diseases.”

About MultiHance

MultiHance is indicated for intravenous use in MRI of the central nervous system in adults and children over 2 years of age to visualize lesions with abnormal blood brain barrier or abnormal vascularity of the brain, spine and associated tissues. It is also approved for MRA to evaluate adults with known or suspected renal or aorto-ilio-femoral occlusive vascular disease.

For additional information about MultiHance, please contact Bracco Diagnostics at Services.Professional@diag.bracco.com.

Please see Important Safety Information below.

For complete prescribing information, please go to www.multihanceusa.com or usa.braccoimaging.com.

About Bracco Imaging

Bracco Imaging S.p.A., part of the Bracco Group, is one of the world’s leading companies in the diagnostic imaging business. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions that meet medical needs.

Bracco Imaging offers a product and solution portfolio for all key diagnostic imaging modalities:

X-Ray Imaging (including Computed Tomography-CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers, and Gastrointestinal Endoscopy. The diagnostic imaging offer is completed by several medical devices and advanced administration systems for contrast imaging products in the fields of radiology.

The Company operates in over 90 countries worldwide, either directly or indirectly through subsidiaries, joint ventures, licenses and distribution partnership agreements. With on-going research programs covering all key modalities, Bracco Imaging has a strong presence in key geographies: North America, Europe and Japan operating through the Joint Venture Bracco-Eisai Co., Ltd. The Company also operates in Brazil, South Korea, and China through the Joint Venture Bracco Sine Pharmaceutical Corp. Ltd.

Operational investments have been made in order to achieve top quality and sustainable eco-friendly production. Manufacturing activities are located in the USA, Canada, Italy, Switzerland, Japan, China and Germany.

Bracco Imaging is an innovative Research and Development (R&D) player with an efficient process oriented approach and a track record of innovation in the diagnostic imaging industry. R&D activities are managed in the three Research Centres located in Italy, Switzerland and the USA.

The Company operates in over 90 countries worldwide, either directly or indirectly, through subsidiaries, joint ventures, licenses and distribution partnership agreements. With an on-going research covering all key modalities, Bracco Imaging has a strong presence in key geographies: North America, Europe and Japan operating through the Joint Venture Bracco-Eisai Co., Ltd. The Company also operates in Brazil, South Korea, and China through the Joint Venture Bracco Sine Pharmaceutical Corp. Ltd.

Operational investments have been made in order to achieve top quality and compliances with a sustainable eco-friendly production, ecology friendly production. Manufacturing activities are located in Italy, Switzerland, Japan, China and Germany.

Bracco Imaging is an innovative Research and Development (R&D) player with an efficient process oriented approach and a track record of innovation in the diagnostic imaging industry. R&D activities are managed in the three Research Centres located in Italy, Switzerland and USA.

IMPORTANT SAFETY INFORMATION:

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS

Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle and internal organs.

•The risk for NSF appears highest among patients with:•chronic, severe kidney disease (GFR <30 mL/min/1.73m2), or

•acute kidney injury.

•Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g. age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.

•For patients at highest risk for NSF, do not exceed the recommended MultiHance dose and allow a sufficient period of time for elimination of the drug from the body prior to re-administration [see Warnings and Precautions (5.1)] †

Anaphylactic and anaphylactoid reactions have been reported, involving cardiovascular, respiratory, and/or cutaneous manifestations ranging from mild to severe. The possibility of a reaction should always be considered, especially in those patients with a history of a known clinical hypersensitivity or a history of asthma or other allergic disorders.

†Please see full Prescribing Information including boxed WARNING at usa.braccoimaging.com or www.multihanceUSA.com.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

All trademarks and registered trademarks are the property of their respective owners.

Contact:

Bracco Diagnostics Inc.

Lakshmi Sundar, 609-514-2236

lakshmi.sundar@diag.bracco.com



   

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