GE Healthcare's Application For DaTSCAN™ (Ioflupane I123 Injection) Accepted By The FDA For Priority Review

Main Category: Neurology / Neuroscience
Also Included In: Regulatory Affairs / Drug Approvals;  Radiology / Nuclear Medicine
Article Date: 04 Jun 2009 - 5:00 PDT

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GE Healthcare announced 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.

"We are very pleased that the FDA has accepted our NDA for DaTSCAN," said Don Black, MD, head of R&D for GE Healthcare Medical Diagnostics. "Acceptance of the NDA filing for priority review is an important milestone for GE Healthcare, and we will continue to work with the FDA with the objective of making DaTSCAN available in the United States."

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.

Source
GE Healthcare