Pharmaprojects R&D Pipeline News Feed
First organ-specific MRI contrast agent approved in the US in over a decade
10 Jul 2008
The US FDA has granted Bayer Schering Pharma marketing approval for its magnetic resonance imaging (MRI) contrast agent, gadoxetate disodium, for the detection and characterisation of liver lesions. The product is currently launched as Primovist in several markets, including Australia, Germany and Switzerland, and is approved in over 40 countries worldwide.
Administered via intravenous injection, gadoxetate disodium is specifically taken up by hepatocytes, enhancing healthy liver tissue. Cancerous tissue is not enhanced, therefore allowing detection of hepatocellular carcinomas, as well as liver metastases and cysts. In addition, its high contrast imaging properties allow identification of tumour structure and intrahepatic vessels, giving an advantage in surgical planning over existing contrast agents.
Dr Gunnar Riemann, of Bayer Schering Pharma said gadoxetate disodium offered the "unique benefit of being able to simultaneously detect, locate and distinguish various types of liver lesions".
Gadoxetate disodium now becomes the first organ-specific MRI contrast agent to gain US approval for over a decade. It will be marketed as Eovist in the US, with launch planned for the summer of 2008.
