FDA denies appeal for MR blood pool agent

The FDA has nixed Epix Pharmaceuticals' appeal of its earlier decision to call for more data regarding the MR blood pool agent Vasovist. The company had asked the agency to approve Vasovist or, alternatively, to refer its request for approval to an FDA advisory committee. The FDA declined both.

FDA reviewers last year issued an "approvable letter" for the agent, but stated that final approval would hinge on submission of additional clinical data to demonstrate its efficacy (DI SCAN, 1/24/05, FDA approvable letter spells bad news for Epix Medical).

In its response, the company tried unsuccessfully to convince reviewers to accept just the data initially submitted. This led to the appeal, filed this year.

In the FDA's response to this appeal, which the company described Aug. 28, the agency suggested that, "If Epix decides to conduct additional clinical research to support approval, rather than relying on a blinded reread of previously submitted data and data from a new clinical trial, a safer course of action would be to conduct two new clinical trials to support the application for approval."

The company might not take the FDA's advice. Epix is exploring several options, according to Andrea Johnston, a spokesperson for the company. Appealing the denial to the next level of the FDA, the Center for Drug Evaluation and Research, is one of those options, she said.

The company first submitted its application to the imaging division, then appealed to the Office of New Drugs, Johnston said. The CDER represents the next level, she said.

Another option, she said, is to conduct more clinical tests to support the data submitted with the application. Before making a decision about which option to choose, the company plans to consult with its board, according to Johnston.

"They will try to make this decision sooner rather than later," she said.