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粮食与药物管理局批准对比染料为焦点肝脏病

Lynn Shapiro, Writer | July 09, 2008
FDA approved Bayer Schering
Pharma's MRI contrast agent
The FDA has approved Bayer Schering Pharma's MRI contrast agent, Primovist (gadoxetate disodium) for the detection and characterization of liver lesions in adults with known or suspected focal liver disease. The product will be marketed in the U.S. under the name Eovist. It is currently being marketed as Primovist outside the U.S. and as EOB Primovist in Japan.

It is the first organ-specific MRI contrast agent to be approved in the U.S. for over a decade, the company says. Bayer plans to make Eovist available to healthcare providers in the U.S. this summer. It is administered by intravenous injection.

"Primovist not only offers the unique benefit of being able to simultaneously detect, locate and distinguish various types of liver lesions, but it also helps to guide and follow up on treatment decisions, as it enables radiologists to identify even tiny pathological liver lesions," says Dr. Gunnar Riemann, member of the board of management of Bayer Schering Pharma, AG.

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"Bayer is now in the unique position of offering Primovist for diagnosing patients with liver cancer and Nexavar for treating hepatocellular carcinoma, the most common form of liver cancer.

Liver cancer is the sixth most common cancer in the world and the third leading cause of cancer-related deaths globally. More than 15,000 cases of liver cancer are diagnosed each year in the U.S. and the incidence is rising.

Earlier staging of primary tumors with metastases in the liver, such as colon cancer, may improve treatment decisions and survival rates. Approximately 510,000 new cases of colon cancer are diagnosed every year globally, more than 200,000 patients per year die of a late-stage of colon cancer.

Primovist was first approved in Europe in 2004 followed by Japan in 2007. It is registered in more than 40 countries.