Epix Pharmaceuticals, Inc., a developer of innovative pharmaceuticals for magnetic resonance imaging (MRI), announced that the Australian Drug Evaluation Committee (ADEC) has recommended to the Therapeutic Goods Administration (TGA) that its novel blood pool imaging agent Vasovist be approved in Australia. Approval is subject to finalization of labelling.
Andrew Uprichard, MD, president and chief operating officer of Epix Pharmaceuticals stated, "The positive opinion on Vasovist from ADEC is another important step forward for Epix. We were recently advised by the US Food and Drug Administration (FDA) that the agency has extended its review of our appeal, and that we should hear its response in September. Meanwhile, Vasovist is gaining momentum in the European Union, and we expect that it will be available in fifteen countries by the end of this year."
Vasovist, Epix's lead product candidate, is an injectable intravascular contrast agent designed to provide visual imaging of the vascular system through magnetic resonance angiography. In October 2005, the European Medicines Agency granted marketing approval of Vasovist for all 25 member states of the EU Schering AG, EPIX's partner for Vasovist, began marketing Vasovist in Europe in the second quarter of 2006.