EPIX Pharmaceuticals, a biopharmaceutical company, has achieved positive results from the blinded, independent re-read of images of its novel blood pool magnetic resonance angiographic (MRA) agent, Vasovist, and plans to resubmit a new drug application (NDA) to the FDA for Vasovist in mid-2008.
In the re-read of images obtained from previous phase 3 studies, EPIX said the MRA agent met all pre-specified endpoints prospectively agreed to with the FDA.
Vasovist is an injectable intravascular contrast agent designed to provide improved imaging of the vascular system through MRA, the company said.
“We believe these positive results confirm the efficacy upon which the NDA was based and allow us to move forward with our strategy of achieving U.S. regulatory approval,” said Andrew Uprichard, MD, president and head of research and development at EPIX.
The Lexington, Mass.-based company said that there are currently no contrast agents approved in the United States for use with MRA, a non-invasive modality for imaging blood vessels. However, it is estimated that approximately 1.5 million MRAs will be conducted in the United States during 2008 using gadolinium-based products.
Vasovist (gadofosveset trisodium) is currently approved for marketing in 33 countries, according to EPIX.