Epix Pharmaceuticals gets an FDA approval
EPIX Pharmaceuticals Inc. of Lexington said that the US Food and Drug Administration has approved a use for Vasovist, its blood pool magnetic resonance angiography agent.
In 2006, the FDA denied approval for Vasovist as an imaging agent for diagnosing vascular diseases, but based on the FDA's decision today, Vasovist can now be marketed in the United States for use in evaluating aortoiliac occlusive disease in adults with known or suspected peripheral vascular disease, EPIX Pharmaceuticals said.
According to the company's press release today, aortoiliac occlusive disease, or AIOD, occurs when iliac arteries become narrowed or blocked and may prevent the sufficient transport of oxygen and/or blood throughout the body.
EPIX Pharmaceuticals added: "Vasovist is the first contrast agent approved for marketing in the United States for use with MRA (magnetic resonance angiography), a non-invasive modality for imaging blood vessels. In 2007, there were approximately 1.3 million MRA procedures performed in the United States using contrast agents not specifically approved for this procedure. MRA is a less invasive procedure than x-ray angiography, allowing for reduced patient discomfort and recuperation time, and unlike x-ray angiography, MRA does not expose patients to ionizing radiation. Vasovist had previously been approved for marketing in 34 countries outside the United States."
To read the company's full press release, please click here.
(By Chris Reidy, Globe staff)