FDA raises questions about clinical data on Datscan
Post date: 2009/8/10 下午 02:57:22
臨床試驗的程序嚴謹非常重要! 一個大廠的產品，很可能因為一個小插曲而整個改觀!
By Jennifer Corbett Dooren
Of DOW JONES NEWSWIRES
WASHINGTON (Dow Jones)--The U.S. Food and Drug Administration on Friday questioned clinical data involving a proposed GE Healthcare imaging agent that would be used in brain scans to help diagnose certain neurological disorders.
The imaging agent, Datscan, faces a review by an FDA panel of outside medical experts next Tuesday. The product is designed to detect the loss of a type of neuron known as a nigrostriatal neuron in the brain and can help diagnose or rule out disorders like Parkinson's disease. The test, however, doesn't directly diagnose such neurological conditions.
The FDA, in a review of the product posted to its Web site Friday, is questioning the data partly because of changes made during the clinical studies that differed from the original design.
"The ability of the data to support the proposed indication remains unclear," the FDA said. However, the agency said it didn't see any major safety issues with Datscan, which would be injected three to six hours before undergoing a scan. Datscan is designed to make nigrostriatal neurons become visible during scans.
Datscan has been on the market in Europe since 2000. There, it is also used to help distinguish between a certain type of dementia and Alzheimer's disease.
The FDA panel will be asked whether Datscan carries a favorable risk-to-benefit profile as a diagnostic tool. The panel will also be asked if Datscan can show the difference between normal and abnormal neuron loss.
GE Healthcare, a unit of General Electric (GE), in a document also posted to FDA's Web site said the product can clearly show the loss of nigrostriatal neurons on a brain scan, which can which can help properly diagnose or rule out certain neurological disorders.
Datscan is being reviewed under FDA's priority-review mechanism, which the FDA grants for products it deems an advance over existing treatments. It also shaves four months off the typical 10-month FDA review period for new drug applications.
By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com