Schering AG of Germany this morning said it has been granted pan-European clearance to market its contrast agent, Vasovist (gadofosveset trisodium), for use in patients with suspected vascular disease in order to visualize the vasculature in the abdomen or limbs and identify – for example – an aneurism (a ballooning of the blood vessel wall) or stenosis (blood vessel narrowing).
These patients would normally have to undergo a catheter-based X-ray angiography, thus Schering hopes this minimally-invasive technology will prove to be a winner. “Vasovist means a real breakthrough in the field of vascular imaging, and we are very proud to be the first to bring a blood pool contrast agent for magnetic resonance imaging to the market,” explained Michael Rook, head of diagnostic imaging at Schering AG.
In Europe alone, some 4 million X-ray angiograms are performed every year.
Schering will be delighted with this approval, particularly after the US Food and Drug Administration delivered a slight knock to Vasovist in January, issuing partner EPIX Pharmaceuticals with an approvable letter. EPIX has since filed additional information with the drug regulator, which has been accepted as a complete response.
Earlier this year, Schering chairman Dr Hubertus Erlen pointed to Vasovist as one of the products that would drive growth in the coming years, with a forecast operating margin of 18% in 2006 on sales of 5.5 million euros [[28/06/05d]].