A Diagnostics & Imaging Week

Schering (Berlin) reported that its development partner, Epix Pharmaceuticals (Cambridge, Massachusetts), received an “approvable” letter from the FDA for Vasovist (gadofosveset trisodium), used in magnetic resonance angiography (MRA).

The letter indicated the need for at least one additional clinical trial and a re-read of images obtained in previously completed Phase III trials before the agency will finally approve Vasovist. No safety or manufacturing issues were raised in the approvable letter, Epix said.

In October, Vasovist was approved in all European Union member states, making it the first in a new class of blood-pool contrast agents for MRA to diagnose vascular disease. The approval is for visualization of abdominal or limb vessels in patients with known or suspected vascular disease such as stenosis or aneurysms.

Schering has the global marketing rights for the product and said it will support Epix in its efforts to address the FDA’s conditions.