FDA Expands Labeling of MultiHance for Magnetic Resonance Angiography
In July 2012 the U.S. Food and Drug Administration (FDA) granted Bracco Diagnostics Inc., the U.S.-based company of the Bracco Group, approval for 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, multicenter 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 percent stenosis) was based on comparisons of sensitivity and specificity between MultiHance MRA and non-contrast MRA, with digital subtraction angiography (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.
For more information: www.bracco.com