FDA Approves DaTscan to Assist in Evaluation of Neurodegenerative Movement Disorders

January 21, 2011

GE Healthcare announced recently that the FDA has approved the first imaging agent to help physicians in evaluating neurodegenerative movement disorders.

GE Healthcare announced recently that the FDA has approved the first imaging agent to help physicians in evaluating neurodegenerative movement disorders.

The FDA approved ioflupane I 123 injection (DaTscan), a radiopharmaceutical agent intended for use with single photon emission computed tomography (SPECT) imaging, for the detection of dopamine transporters in the brains of adult patients with suspected parkinsonian syndromes.

Along with other evaluations, DaTscan may be used to differentiate essential tremor from tremors due to these syndromes, the company said.

“It is important for me to provide a patient as confident as diagnosis as possible,” said Mark Stacy, MD, neurologist and director of the Duke Movement Disorders Clinic at Duke University Medical Center in Durham, NC, and a consultant to GE Healthcare in the development of DaTscan. “In cases where there is not a clear constellation of clinical signs pointing to Parkinson's disease or essential tremor, DaTscan may help me counsel a patient with more confidence. I think this is helpful to the patient in the long run.”

The DaTscan could supplant some evaluations, Stacy said in an interview, such as an MRI or CT scan. In some cases, it may make more sense to use the DaTscan, he said.

FDA’s move, after priority review, is the first approval of a radiopharmaceutical agent to detect DaT distribution in the brain, according to the company. The FDA grated priority review “due to an unmet clinical need for an imaging agent to assist physicians in managing patients according to their dopaminergic status,” the company said.

Stacy said that movement disorders are now diagnosed through clinical exams, blood tests, and neuropsychological evaluations, which are not conclusive. “A new diagnostic adjunct to existing clinical assessments represents a meaningful contribution to the movement disorders field,” he said in the statement.

According to Medscape Medical News, a few members of the FDA advisory panel expressed some concerns about the product last fall. Members who voted against the agent questioned its safety, and one member voiced concern that it wasn’t cost-effective.

Stacy noted that the FDA reviewed the data and approved the agent, and that the DaTscan has been used in Europe since 2000.