Epix imaging agent gets FDA response

Epix Pharmaceuticals Inc. of Lexington said it may be able to obtain regulatory approval of its radiology imaging agent Vasovist without further clinical trials.

The company said it has received a response from the Food and Drug Administration in regard to its appeal for immediate approval of Vasovist, which is designed to help detect vascular disease.

While denying immediate approval, the FDA indicated that further clinical tests may be unnecessary; instead, a "blinded reread" of results from previous tests may be sufficient to support approval, Epix said.

Epix has scheduled an investor conference call for this morning to further discuss the FDA's response.

According to the company, Vasovist is an injectable intravascular contrast agent designed to provide visual imaging of the vascular system.
(By Chris Reidy, Globe staff)