A U.S. Food and Drug Administration (FDA) advisory panel will meet on August 11 to discuss GE Healthcare's new drug application (NDA) for DaTscan (ioflupane iodine-123 injection).
The meeting of the Peripheral and Central Nervous System Drugs Advisory Committee will discuss the NDA for the radiopharmaceutical, with a proposed indication for brain imaging of patients with movement disorders such as Parkinson's disease.
DaTscan is the Chalfont St. Giles, U.K.-based company's radiopharmaceutical intended for detecting loss of functional nigrostriatal dopaminergic neurons in SPECT imaging in patients presenting with symptoms or signs suggestive of dopaminergic neurodegeneration.
In June, the FDA accepted GE's NDA for DaTscan for priority review, a designation for drugs that offer major advances in treatment or provide treatment where no adequate therapy exists.
Prior to the August 11 meeting, the committee sent a memo to GE to ask how DaTscan would help diagnose movement disorders.
According to a Reuters report, the memo asserted that GE's data for the indication are "unclear" and that the drug may need to be used for a different indication. The report also noted that the FDA committee questioned GE's studies, writing in the communiqué that they "are inconsistent with the type of design and conduct usually anticipated" for imaging agents.
The FDA panel plans to discuss these issues at the August 11 meeting.
DaTscan has been available since 2000 in Europe, where it is indicated for detecting loss of functional dopaminergic neuron terminals in the striatum in patients with clinically uncertain Parkinsonian syndromes, to help differentiate essential tremor from Parkinsonian syndromes related to idiopathic Parkinson's disease (PD), multiple system atrophy (MSA), and progressive supranuclear palsy (PSP).
DaTscan is unable to discriminate between PD, MSA, and PSP, the company said.
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