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Bayer's liver agent approved by FDA
08 Jul 2008
Regulatory Affairs
Bayer Schering Pharma says its magnetic resonance imaging (MRI) contrast agent Primovist has been granted approval by the US Food and Drug Administration (FDA).
The company states Primovist is used for detecting and characterising liver lesions in adults who have either suspected or confirmed focal liver disease.
It reports Primovist is the first organ-specific MRI contrast agent to be approved in the US for over a decade.
Dr Gunnar Riemann, responsible for Bayer Schering’s business units and member of the board of management, said the agent offers the "unique benefit of being able to simultaneously detect, locate and distinguish various types of liver lesions".
He added it also helps in guiding treatment decisions and is able to help identify "even tiny pathological liver lesions".
Bayer recently announced it had acquired the haemophilia development portfolio of the biopharmaceutical company Maxygen.
Dr Gunnar Riemann stated the move fits in with his company's strategy of expanding its speciality pharmaceutical business.
