Lantheus Medical Imaging has launched Ablavar (gadofosveset trisodium), an injectable MR angiography (MRA) imaging agent used to evaluate aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease.
Ablavar is the only contrast imaging agent approved in the U.S. for use with an MRA indication to evaluate AIOD.
Ablavar is contraindicated if the patient has a history of a prior allergic reaction to a gadolinium-based contrast agent. Also, its warning label states that gadolinium-based contrast agents increase the risk of nephrogenic systemic fibrosis in patients with acute or chronic severe renal insufficiency (glomerular filtration rate less than 30 mL/min/1.73m2), or acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.
Ablavar was formerly marketed as Vasovist by Epix Pharmaceuticals, which, in an effort to avoid bankruptcy, sold the U.S., Canadian and Australian rights for the blood pool agent, to the North Billerica, Mass.-based Lantheus for aggregate gross cash proceeds of $28 million. Vasovist gained FDA approval to evaluate AIOD in adults with known or suspected peripheral vascular disease in December 2008, making it the first contrast agent approved for marketing in the U.S. for use with MRA.