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MARLBOROUGH, Mass.--(BUSINESS WIRE)--Nov 3, 2022--
GE Healthcare’s DaTscan has been approved by the U.S. Food and Drug Administration (FDA) for use in patients with suspected Dementia with Lewy Bodies (DLB). This new indication is in addition to its use with single photon emission computed tomography (SPECT) imaging to visualize dopamine transporters (DaT) in the brains of adult patients with suspected Parkinsonian syndromes. With the expanded indication, DaTscan is now available to more patients, including those with suspected DLB, in the United States.
The clinical signs and symptoms of DLB can be atypical and overlap with other forms of dementia, leading to up to 70% of patients with DLB being misdiagnosed, often as having Alzheimer’s Disease ii. This new indication enables clinicians to use DaTscan to help differentiate DLB from other forms of dementia. Early and accurate diagnosis of DLB can help ensure specific appropriate treatment and specialized care for patients, while enabling them and their caregivers to more effectively manage the disease and plan for the future iii.
Approximately one in five patients with dementia suffers from DLB, making it the second most common form of degenerative dementia after Alzheimer’s Disease i.
Professor James E. Galvin, MD, MPH, Consultant, University of Miami Miller School of Medicine, U.S., said: “Misdiagnosis is a significant issue for those patients with suspected Dementia with Lewy Bodies, causing untold anxiety for the patient and family as well as potentially placing the patient at higher risk of adverse events due to delayed diagnosis. The label expansion for DaTscan moves patients a step closer to an earlier, more accurate, diagnosis which is beneficial for them and their families, setting them on the right treatment path sooner and helping to avoid medications and treatments that could be potentially harmful.”
Mark Hibberd, Chief Medical Officer for GE Healthcare Pharmaceutical Diagnostics, said: “More than one million doses of DaTscan have already been used around the world in the clinical evaluation of Parkinsonian syndromes. We have built on our scientific and medical leadership with DaTscan to pave the path for this new indication, that supports our customers and their patients with more accurate diagnoses of DLB.”
The approval of the use of DaTscan in DLB is the culmination of significant work, including clinical trials, compilation and analysis of data and collating evidence for submission to the U.S. FDA, all demonstrating GE Healthcare’s continued commitment and investment in this space.
Earlier this year, GE Healthcare announced plans to bolster its Molecular Imaging neurology portfolio by complementing DaTscan with two pipeline radiopharmaceuticals, one for Positron Emission Tomography (PET) and another for SPECT, aiming to offer customers, in both clinical and research settings, a wider choice of diagnostic tracers to help evaluate adult patients with suspected Parkinsonian syndromes.
GE Healthcare’s Pharmaceutical Diagnostics unit is a global leader in imaging agents used to support around 100 million procedures per year globally, equivalent to three patient procedures every second. Its Molecular Imaging portfolio combines established proprietary products across cardiology, neurology and oncology, with an innovative pipeline, all aimed at enabling better diagnosis and monitoring for improved therapy decision-making and clinical outcomes.
References:
i Barker, Warren W et al. “Relative frequencies of Alzheimer disease, Lewy body, vascular and frontotemporal dementia, and hippocampal sclerosis in the State of Florida Brain Bank.” Alzheimer disease and associated disorders vol. 16,4 (2002): 203-12. doi:10.1097/00002093-200210000-00001
ii Warr et al. Q J Nucl Med Mol Imaging; 2012; 56: 39-54
iii Zweig and Galvin Alzheimer’s Research & Therapy 2014, 6.21; http://alzres.com/content/6/2/21
Product Indications and Important Safety Information – DaTscan
PRODUCT INDICATION AND USE
DATSCAN is indicated as an adjunct to other diagnostic evaluations for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging in adult patients with:
Important Safety Information About DaTscan™ (ioflupane I 123 injection)
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
DRUG INTERACTIONS
USE IN SPECIFIC POPULATIONS
OVERDOSAGE
PROCEDURE — Radiation Safety
Prior to DaTscan administration, please read the fullPrescribing Informationfor additionalImportant Safety Information.
To report SUSPECTED ADVERSE REACTIONS, contact GE Healthcare at 800 654 0118 (option 2, then option 1) or the FDA at 800 FDA 1088 or www.fda.gov/medwatch.
About DaTscan
DaTscan is a radiopharmaceutical imaging agent that works by binding to dopamine transporters (DaT) in the brain. A specific marker for DaT, DaTscan produces images that provide visual evidence based on the density of dopamine transporters.
DaTscan was the first FDA-approved radiopharmaceutical adjunct imaging agent to help physicians evaluate patients with suspected Parkinsonian syndromes (PS), such as Parkinson's disease (PD).
DaTscan has been available in the US since 2011 and has been used in more than 1 million patients in 40 countries.
About GE Healthcare:
GE Healthcare is the $17.7 billion healthcare business of GE (NYSE: GE). As a leading global medical technology, pharmaceutical diagnostics and digital solutions innovator, GE Healthcare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence platform. With over 100 years of healthcare industry experience and around 48,000 employees globally, the company operates at the center of an ecosystem working toward precision health, digitizing healthcare, helping drive productivity and improve outcomes for patients, providers, health systems and researchers around the world.
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CONTACT: Media Contact:
Debbie Leven
Debbie.Leven@ge.com
+44 7785 456999
KEYWORD: MASSACHUSETTS UNITED STATES NORTH AMERICA
INDUSTRY KEYWORD: NEUROLOGY RADIOLOGY BIOTECHNOLOGY PHARMACEUTICAL HEALTH FDA MEDICAL DEVICES CLINICAL TRIALS
SOURCE: GE Healthcare
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PUB: 11/03/2022 08:22 AM/DISC: 11/03/2022 08:22 AM
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