Epix Pharmaceuticals, Inc. has announced that Health Canada's Health Products and Food Branch (HPFB) has approved its novel blood pool imaging agent Vasovist for marketing in Canada.
Vasovist (gadofosveset trisodium injection) is indicated for contrast-enhanced magnetic resonance angiography (MRA) for visualization of abdominal or limb vessels in patients with suspected or known vascular disease.
"We are delighted with this approval of Vasovist in Canada, which represents the 30th country in which Vasovist is approved for marketing," stated Andrew Uprichard, MD, president of EPIX Pharmaceuticals. "We remain in dialogue with the US FDA administration regarding the path to approval for Vasovist in the US."
Dr Uprichard added, "In addition to this milestone for Vasovist, data from our phase 2a clinical trial of EP-2104R, our novel thrombus imaging agent, will be the subject of an oral presentation at the Radiological Society of North America (RSNA) later this month. These achievements further demonstrate the significant progress we have made in the clinical development of our robust pipeline of novel imaging and therapeutic product candidates."
Vasovist is an injectable intravascular contrast agent designed to provide visual imaging of the vascular system through magnetic resonance angiography, which has been developed in collaboration with and will be marketed by Schering AG, Germany. The initial target indication for Vasovist is for use in magnetic resonance angiography imaging of non-coronary vascular disease.
Epix Pharmaceuticals is a biopharmaceutical company focused on discovering, developing and commercialising novel pharmaceutical products through the use of proprietary technology to better diagnose, treat and manage patients.