Schering AG gets first approval for Resovist

Germany's Schering AG has been granted its first approval, in Sweden,for a new magnetic resonance imaging contrast medium designed to help detect and characterize especially small lesions in the liver. Resovist (ferucarbotran) is expected to be used in the early detection of hepatic carcinoma and liver metastases.

Based on the Swedish decision, Schering now plans to seek approval of Resovist throughout the European Union via the mutual recognition procedure, and expects to launch the product in mid-2001. An application for approval in Japan has also been submitted, notes the firm. Schering is the leader in the MRI contrast agent market, with more than a 60% share, and its largest product in this sector is Magnevist (gadopentetate dimeglumine), with sales up 23% in 2000 to 286 million euros ($256 million).

Resovist can be administered as a bolus injection at a fixed-volume dose, depending on body weight, a significant advantage over current contrast agents for liver imaging that require slow injections or infusions. In addition to allowing detection of lesions at an earlier stage than at present, the new agent may also make it easier to differentiate malignant and non-malignant lesions, improving the selection of appropriate therapy.