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GE Healthcare’s Application for DaTSCAN™ Given Priority Review by the FDA to Help Detect Dementia with Lewy Bodies (DLB) often m

Posted Jun 03 2009 10:19am

Dementia with Lewy Bodies (DLB) has been difficult to diagnose, and is often misdiagnosed as Alzheimer's disease.   Nuclear medicine scans can help determine whether a patient has Alzheimer's or the beginning effects of Parkinson’s Disease.  Lewy Body Disease is actually the second most common cause of dementia.  Symptoms include hallucinations, sensitivity to antipsychotic drugs, and symptoms that change. image

The hope here is to diagnose properly and not confuse the disease with Parkinson's or Alzheimer's so correct treatments plans can be given.  BD 

From the website:

DaTSCAN is appropriate for patients referred by physicians experienced in the management of movement disorders and/or dementia. It should only be used by professionals with the appropriate government authorization for the use of radionuclides within a clinical setting.[1]

The complete procedure takes about half a day to complete. An injectable solution is given intravenously three hours before the scan. A gamma camera is used to produce 3-D reconstructed images.

GE Healthcare announced today that the Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for DaTSCAN (Ioflupane I123 Injection) for priority review. DaTSCAN is a radiopharmaceutical agent containing Ioflupane (¹²³I) in development for a proposed indication of the detection of loss of functional nigrostraiatal dopaminergic neurons by single photon emission computed tomography (SPECT) imaging in patients presenting with symptoms or signs suggestive of dopaminergic neurodegeneration. 

A priority review designation is intended for drugs that offer major advances in treatment, or provide treatment where no adequate therapy exists. The FDA's goal is to review and act on 90 percent of NDAs designated as priority review within six months of receipt.

DaTSCAN has been available in Europe since 2000. In Europe, DaTSCAN is indicated for detecting loss of functional dopaminergic neuron terminals in the striatum in patients with clinically uncertain Parkinsonian Syndromes in order to help differentiate Essential Tremor from Parkinsonian Syndromes related to idiopathic Parkinson’s Disease (PD), Multiple System Atrophy (MSA), Progressive Supranuclear Palsy (PSP). DaTSCAN is unable to discriminate between PD, MSA and PSP. In Europe, it is also indicated to help differentiate probable dementia with Lewy bodies (DLB) from Alzheimer’s disease. DaTSCAN is unable to discriminate between DLB and Parkinson’s disease dementia.

EuroInvestor.co.uk - GE Healthcare’s Application for DaTSCAN™ (Ioflupane I123 Injection) Accepted by the FDA for Priority Review

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