Schering AG/Epix' contrast agent Vasovist (gadofosveset trisodium) has received approval in Europe, despite facing further data requests from FDA.

Vasovist (formerly MS-325) was approved for "visualization of abdominal or limb vessels in patients with known or suspected vascular disease such as stenosis and aneurysms" in conjunction with magnetic resonance angiography, the firms said Oct. 5.

Manufacturer Epix is still waiting for U.S. approval. The firm submitted an NDA in December 2003. Classifying a reanalysis of data as a major amendment, FDA later extended the user fee date by three months to January 2005.

In January 2005, FDA issued an "approvable" letter for Vasovist, requesting additional studies due to a possible confounding effect caused by uninterpretable images in the non-contrast control group (¹ Also see "Schering AG/Epix' Imaging Agent Requires Additional Clinical Studies, FDA Says" - Pink Sheet, 14 January, 2005.).

The firm submitted a response to FDA in May, giving the NDA a Nov. 23 user fee date. However, the response did not include efficacy data from new clinical trials, which FDA had specifically requested.

According to Epix' marketing partner Schering AG, Vasovist's four multicenter Phase III trials "showed a statistically significant improvement in diagnostic efficacy compared to unenhanced MRA."

- Kathleen Michael

Schering AG/Epix Contrast Agent Vasovist Gains EU Approval, Waits For FDA

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