EPIX Pharmaceuticals, Inc. has reached agreement with the US Food and Drug Administration (FDA) on its proposal for the re-read of images of its novel blood pool magnetic resonance angiographic (MRA) agent, Vasovist (gadofosveset trisodium).
EPIX has received an action letter from the FDA confirming that the jointly agreed-upon protocol design and statistical analysis plan adequately address the objectives necessary to support the resubmission of the New Drug Application (NDA) for Vasovist. EPIX has initiated the re-read of images obtained in prior phase III studies. Vasovist has been approved for marketing in 33 countries outside of the US.
"We are extremely pleased with the progress we have made with the FDA," said Andrew Uprichard, MD, Ph.D., president and head of research and development at EPIX. "We have designed a protocol with input from the FDA that outlines the methodology of conducting the re-read of images and the statistical analysis of the data. As we announced in June 2007, the FDA has indicated that a blinded re-read of the images obtained from the previously completed phase III clinical trials of Vasovist could support approval if the results meet the pre-specified endpoints agreed with the Agency. We expect to submit these results in mid 2008".
Vasovist is an injectable intravascular contrast agent designed to provide visual imaging of the vascular system through magnetic resonance angiography imaging (MRA). The initial target indication for Vasovist is for use in MRA imaging of the non-coronary vascular system. Vasovist has been approved for marketing in 33 countries, including among others all 27 member states of the European Union, Switzerland, Turkey, Australia and Canada. The marketing rights to Vasovist are held by Bayer Schering Pharma in Europe and by Bayer HealthCare Pharmaceuticals in the United States and Canada. Both companies are part of Bayer AG. Vasovist is currently marketed in Canada and 18 European countries, including among others Germany, the Netherlands, Italy, all Nordic countries, United Kingdom, and Switzerland.