Friday, April 25, 2008
Vasovist, a Vascular MRI Contrast Agent, Meets FDA Requirements
Filed under: Radiology
, Vascular Surgery
Epix Pharmaceuticals Inc., an Israeli firm that has developed Vasovist (gadofosveset trisodium), a novel MRI contrast agent, has announced that its product "has achieved positive results from the blinded, independent re-read of images of its novel blood pool magnetic resonance angiographic (MRA) agent, Vasovist. In the re-read of images obtained from previous phase 3 studies, EPIX met all pre-specified endpoints prospectively agreed to with the U.S. Food and Drug Administration (FDA). EPIX plans to resubmit a New Drug Application (NDA) to the FDA for Vasovist in mid-2008. Vasovist is currently approved for marketing in 33 countries." And that includes the European Union, where the device (as it is classified) has been marketed (in collaboration with Schering AG) since 2005.
Here's how the agent is described:
Vasovist® is an injectable intravascular contrast agent discovered internally at EPIX and is designed to provide improved imaging of the vascular system using magnetic resonance angiography (MRA). EPIX's initial target indication for Vasovist is for use in MRA imaging of peripheral vascular disease, providing a breakthrough in the physician's ability to visualize the human vascular system and improve disease diagnosis and treatment.Vasovist reversibly binds to the human blood protein albumin, allowing imaging of the blood vessels for approximately an hour after administration. With a single injection, Vasovist enables clear three-dimensional images of arteries and veins throughout the body. Vasovist may make it possible for physicians to detect vascular disease earlier and less invasively than with X-ray angiography, and provide an improved evaluation of potential therapeutic options including percutaneous intervention and vascular surgery.
Press release: EPIX Pharmaceuticals Announces Positive Results From Re-Read of Vasovist(R) Phase 3 Images...
Product page: Vasovist...
More from Globes: Epix imaging device meets FDA requirements...
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