Lantheus Medical Imaging Inc. launched a new drug for us in magnetic resonance angiography procedures, Ablavar, that contains a controversial element believed to play a role in causing a debilitating kidney condition in patients with severe renal disease.
The Billerica, Mass.-based company said its gadofosveset trisodium imaging agent is the only such drug approved in the U.S. for use in MRA procedures. It’s designed to evaluate aortoiliac occlusive disease in adults with peripheral vascular disease.
The drug is designed to allow multiple images to be obtained using a single, low dose injection, Lantheus said. It’s been cleared in 37 countries other than the U.S. and has been used in about 90,000 patients, according to the company.
Ablavar contains the element gadolinium, which has been linked to cases of nephrogenic systemic fibrosis in patients with severe kidney disease. Late last year, a Food & Drug Administration advisory panel recommended that the watchdog agency tighten restrictions on drugs containing the element.
