RSNA: Lantheus touts MR angiography agent
Lantheus Medical Imaging touted the benefits of its recently acquired MR angiography (MRA) agent, Ablavar (formerly marketed as Vasovist, gadofosveset trisodium), at the 2009 Radiological Society of North America in Chicago earlier this month.
In April, Epix Pharmaceuticals, in an effort to avoid bankruptcy, sold the U.S., Canadian and Australian rights for its blood pool MRA agent, Vasovist, to Lantheus for aggregate gross cash proceeds of $28 million. Vasovist gained FDA approval to evaluate aortoiliac occlusive disease 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.
However, Ablavar is not currently being sold in the U.S., explained Mark Hibberd, MD, PhD, senior medical director at Lantheus. “The company is still waiting for the FDA to make some administrative changes to the labeling. Even though all the safety and efficacy data has been approved by the FDA, we are simply waiting for the labeling changes with our branding, which all need to be reviewed by numerous divisions of the FDA.”
Hibberd had hoped to launch to the U.S. market by the end of 2009, but they were waiting on the FDA’s final word for the labeling changes.
Ablavar is an injectable intravascular gadolinium-based contrast agent designed to provide imaging of the vascular system, specifically for peripherally vascular disease, through MRA. Hibberd noted that the alternative to using this type of agent for the assessment is CT or x-ray angiography, “which carry with them big radiation doses.”
“With other gadolium agents, timing is crucial. Ablavar circulates throughout the body—without leaking into the tissues—and binds to blood proteins, so the patient can be imaged for up to an hour,” he said.
In April, Epix Pharmaceuticals, in an effort to avoid bankruptcy, sold the U.S., Canadian and Australian rights for its blood pool MRA agent, Vasovist, to Lantheus for aggregate gross cash proceeds of $28 million. Vasovist gained FDA approval to evaluate aortoiliac occlusive disease 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.
However, Ablavar is not currently being sold in the U.S., explained Mark Hibberd, MD, PhD, senior medical director at Lantheus. “The company is still waiting for the FDA to make some administrative changes to the labeling. Even though all the safety and efficacy data has been approved by the FDA, we are simply waiting for the labeling changes with our branding, which all need to be reviewed by numerous divisions of the FDA.”
Hibberd had hoped to launch to the U.S. market by the end of 2009, but they were waiting on the FDA’s final word for the labeling changes.
Ablavar is an injectable intravascular gadolinium-based contrast agent designed to provide imaging of the vascular system, specifically for peripherally vascular disease, through MRA. Hibberd noted that the alternative to using this type of agent for the assessment is CT or x-ray angiography, “which carry with them big radiation doses.”
“With other gadolium agents, timing is crucial. Ablavar circulates throughout the body—without leaking into the tissues—and binds to blood proteins, so the patient can be imaged for up to an hour,” he said.