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US Panel: GE Brain Imaging Drug May Be Useful

SILVER SPRING, MD - Aug 11 2009

By Susan Heavey (Reuters)

An experimental GE Healthcare brain imaging drug can serve as an additional tool for doctors in evaluating patients with signs of possible movement disorders such as Parkinson's disease, a U.S. medical advisory panel said on Tuesday.

A Food and Drug Administration panel of outside experts, in an 11-2 vote, told the agency that the benefits of using the drug with imaging scans outweighed its few risks. One panelist abstained.

GE Healthcare, a unit of General Electric Co (GE.N), is seeking FDA approval of its radioactive injectable drug, called DaTSCAN, for use with single photon emission computed tomography, or SPECT, imaging scans to help detect the loss of certain neurons in the brain.

Although it was not very clear which exact patients would benefit or how precisely doctors would use it to determine the best treatments, most panelists agreed the drug could help provide useful information about the presence of neurons carrying dopamine, a critical protein for body movement.

Panelist Dr. Nathan Fountain, a University of Virginia neurologist, estimated that the drug "might make a difference in maybe 5 percent" of patients with possible movement disorders seen by specialists and 15 percent of those seen by a general practitioner.

"If there are 5 percent of my patients who could benefit from a more exact diagnosis and better treatment, that's worth it," said Dr. Samuel Frank, a neurologist at Boston University. He added the scans should not replace physicans' judgment.

The FDA, which is not bound by the panel's recommendation, will weigh the vote before later making an approval decision. The company is expecting to hear from the FDA by Sept. 9.

Still, some panelists expressed caution about wider use of the drug and accompanying scan.

The FDA and company have suggested that if approved, the diagnostic drug be limited to use in patients who already show signs of possible degenerative disease.

"I have reservations about how widely and in what clinical situation it might be used," said panelist Dr. Peter Herscovitch of the National Institutes of Health's Clinical Center, who voted for the drug. He added that he would not want the drug used as a screening tool by general practitioners.

GE Healthcare officials said the panel not only agreed that the company's product could be useful but also helped set the direction for future molecular imaging products after the FDA released new product development guidelines in 2004 to help companies decide what kind of data they needed for approval.

Don Black, head of research and development for GE Healthcare Medical Diagnostics, said the committee's backing helped show that different types of data could be used.

That could spur more confidence and investment in diagnostic drugs like DaTSCAN that "don't have the same level of rewards that a (more traditional) therapeutic drug does," he told Reuters after the panel.

But Dr. Joel Perlmutter, a neurologist at Washington University at St. Louis who the FDA asked to speak at the meeting, questioned whether an expensive scan was worth it. While they can be useful for research, it's not clear how scans help patients when current drugs only treat symptoms but don't curb the disease, he said.

He estimated the scan can cost about $1,500 compared to medications that average around $150. "I think the cost-benefit is marginal" when drugs are "a lot cheaper," he said.

(Reporting by Susan Heavey; editing by Carol Bishopric, Bernard Orr)

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