MRI contrast developer Epix Pharmaceuticals has received a response from its appeal to the U.S. Food and Drug Administration (FDA) asking for immediate approval of its Vasovist agent.
While the FDA has denied the immediate approval of Vasovist, it indicated that further clinical trials may not be necessary to gain approval, according to the Lexington, MA-based firm. Instead, the FDA stated that a blinded reread of the images obtained from previous phase III trials could support approval if the results are positive, Epix said.
Epix said it intends to quickly begin working with the FDA's Division of Medical Imaging and Hematology Products to develop a jointly agreed-upon protocol for blinded reanalysis of the phase III images. After the rereads are completed, Epix will file an amended submission.
By AuntMinnie.com staff writers
June 19, 2007
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