Epix Pharmaceuticals Inc. (Nasdaq:EPIX) today announced that it met US Food and Drug Administration (FDA) requirements for the re-read of images obtained from previous phase III trials of its novel blood pool magnetic resonance angiographic (MRA) agent, Vasovist (gadofosveset trisodium). The share jumped 26% to $1.71 by afternoon on Nasdaq on the news.
). Epix plans to resubmit a New Drug Application to the FDA for Vasovist in mid-2008. Vasovist is currently approved for marketing in 33 countries. It aims to improve MRA images of blood vessels. The company first filed a drug application with the FDA in 2006, but the FDA rejected the application on the basis of the data submitted. The rejection severely hurt the company's share.
Epix appealed the decision, and after lengthy negotiations, the FDA agreed to a re-read of the data and set targets for the company to meet.
Epix noted that there are currently no contrast agents approved in the US for use with MRA, a non-invasive modality for imaging blood vessels, but approximately 1.5 million MRAs will be conducted in the US during 2008 using gadolinium-based products.
Published by Globes [online], Israel business news - www.globes-online.com - on April 24, 2008
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