GE Healthcare announced today the FDA has approved DaTscan™
(Ioflupane I 123 Injection), a radiopharmaceutical agent intended for use with
single photon emission computed tomography (SPECT) imaging, for the detection
of dopamine transporters (DaT) in the brains of adult patients with suspected
Parkinsonian syndromes (PS).The first FDA-approved diagnostic imaging agent to
help physicians evaluate neurodegenerative movement disorders, such as
idiopathic (of unknown cause) Parkinson’s disease (PD), DaTscan may be used as
an adjunct to other diagnostic evaluations to help differentiate essential
tremor (an involuntary shaking of the hands, head, and face ) from tremor due
to PS. DaTscan cannot differentiate between the different types of PS.
“Ioflupane (DaTscan)
may be an important new imaging agent for physicians in differentiating
diseases such as Parkinson’s disease from Essential Tremor,” said Mark Stacy,
MD, neurologist and director of the Duke Movement Disorders Clinic at Duke University
Medical Center
in Durham, NC. “Understanding exactly what you are
dealing with is important in selecting the appropriate treatments for patients
with movement disorders.”
The FDA’s action, following a Priority Review, marks the
approval of the first radiopharmaceutical agent to detect DaT distribution
within the brain (dopamine is a brain chemical that is classified as a neurotransmitter
and is found in regions of the brain that regulate activities such as movement
and emotion). The FDA granted DaTscan Priority Review due to an unmet clinical
need for an imaging agent to assist physicians in managing patients according
to their dopaminergic status. Parkinsonian syndromes are a group of
neurodegenerative disorders (including multiple system atrophy, progressive
supranuclear palsy and idiopathic Parkinson’s disease) characterized by
rigidity, tremor and an impaired ability to walk.
“Currently, movement disorders are diagnosed through
clinical examinations, blood tests and neuropsychological evaluations, which
are not conclusive and may lead to misdiagnosis,” Dr. Stacy said. “A new
diagnostic adjunct to existing clinical assessments represents a meaningful
contribution to the movement disorders field.”
The FDA’s approval of DaTscan was based on two Phase 3
clinical trials confirming the efficacy of DaTscan for the visualization of DaT
distribution within the striata, an interior part of the brain. These studies,
evaluating 284 adult patients with tremor, demonstrated the consistent
performance of DaTscan in the visual detection of DaT distribution in the brain
when compared with a reference clinical diagnosis.
“We are confident that DaTscan, an objective and
accurate marker of dopamine transporters, will better inform physicians’
diagnostic decisions,” said Stephen Lightfoot, MI-SPECT Segment Leader, GE
Healthcare Medical Diagnostics. “By potentially enabling better disease
management, we expect that DaTscan will greatly benefit the patient community.”
