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U.S. federal regulators approved Vasovist, EPIX Pharmaceuticals Inc.’s blood pool magnetic resonance angiography agent, the biopharmaceutical company announced on Monday.
EPIX Pharmaceuticals received an approvable letter from the U.S. Food and Drug Administration for its Vasovist (gadofosveset trisodium), an injectable intravascular contrast agent created to provide enhanced imaging of the vascular system using magnetic resonance angiography (MRA).
According to John Jenkins, the FDA official in charge of new drugs, "this MRA contrast imaging agent provides clinicians with a much clearer scan of blood vessels, compared to MRA without contrast, even in vessels that are difficult to scan because they twist and turn in the body."
Vasovist has been approved for marketing in 34 countries outside the United States, Canada, Switzerland and Turkey counting among them. The active substance in the product is called gadolinium and is a rare element, used in medical applications. When injected, it interacts with water molecules in the body, giving a better picture of blood vessels and, therefore, allowing doctors to find blockages or other vessel complications.
Vasovist also provides the following benefits: no patient exposure to ionizing radiation; less invasive than X-ray angiography, reducing patient discomfort and recuperation time; complete vascular exam of multiple body regions for a more complete diagnosis, as well as visualization of vessel wall structures.
At 2 p.m. on Dec. 24, the stock price was trading at $1.40. Stock prices during the year varied from 21 cents to $4.41.
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