Bracco Diagnostics Inc. said Friday it received Food and Drug Administration approval to expand the indications of an MRI imaging agent used to detect brain tumors to now cover certain types of arterial disease.
Bracco said the drug, Multihance (gadobenate dimeglumine), now has been expanded for use in magnetic resonance angiographies to help diagnose stenosis in the renal and aorto-ilio-femoral arteries. The gadolinium-based contrast agent was originally approved by the FDA in 2004 for MRI scans of the central nervous system in children and adults.
The company said the approval came about after Bracco conducted two large, multi-center, prospective trials on the new indication.
As with other GBCAs, Multihance carries a black box warning label because of the risk of nephrogenic systemic fibrosis, believed to be an extremely rare side effect for patients with kidney problems who receive GBCA injections. However, in a statement, Dr. Alberto Spinazzi, senior vice president of regulatory affairs with Bracco, said Multihance carries a "strong record of safety" and has been administered more than 14 million times.
"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," he said.
