MARLBOROUGH, Mass.–(COMMERCIAL WIRE)–GE Healthcare’s DaTscan has been approved by the US Food and Drug Administration (FDA) for use in patients with suspected dementia with Lewy bodies (DLB). This new indication adds to its use with single photon emission computed tomography (SPECT) imaging to visualize dopamine transporters (DaT) in the brain 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 may overlap with other forms of dementia, leading to up to 70% of DLB patients being misdiagnosed, often with Alzheimer’s disease.me. This new indication allows clinicians to use DaTscan to help differentiate DLB from other forms of dementia. Early and accurate diagnosis of DLB can help ensure appropriate specific treatment and specialized care for patients, while allowing them and their caregivers to more effectively manage the disease and plan for the future.III.
About one in five dementia patients suffer from MCI, making it the second most common form of degenerative dementia after Alzheimer’s disease.Yo.
Professor James E. Galvin, MD, MPH, Consultant, University of Miami Miller School of Medicine, USA, said: “Misdiagnosis is a major problem for those patients with suspected Lewy body dementia, causing untold anxiety for the patient and family, as well as putting the patient at increased risk of adverse events due to late diagnosis. Label expansion for DaTscan brings patients one step closer to earlier, more accurate diagnosis that is beneficial to them and their families, putting them on the right treatment path sooner and helping them avoid potentially harmful drugs and treatments ”.
Mark Hibberd, chief medical officer of GE Healthcare Pharmaceutical Diagnostics, said: “More than one million doses of DaTscan have already been used worldwide in the clinical evaluation of Parkinsonian syndromes. We have built on our scientific and medical leadership with DaTscan to pave the way for this new indication, which supports our customers and their patients with more accurate diagnoses of DLB.”
The approval of DaTscan for use in DLB is the culmination of significant work, including clinical trials, data compilation and analysis, and evidence collation for submission to the US FDA, all of which demonstrate the continued commitment and GE Healthcare’s investment in this space.
Earlier this year, GE Healthcare announced plans to bolster its molecular imaging neurology portfolio by complementing DaTscan with two radiopharmaceuticals in development, one for positron emission tomography (PET) and one for SPECT, with the goal of offering customers , in both clinical and research settings, a broader choice of diagnostic tracers to help evaluate adult patients with suspected parkinsonian syndromes.
GE Healthcare’s Pharmaceutical Diagnostics unit is a world leader in imaging agents used to support around 100 million procedures per year worldwide, which is equivalent to three patient procedures every second. Its Molecular Imaging portfolio combines established proprietary products in cardiology, neurology and oncology, with an innovative portfolio, all aimed at enabling better diagnosis and monitoring to improve therapy decision-making and clinical outcomes.
Yo Barker, WarrenW et al. “Relative frequencies of Alzheimer’s disease, Lewy bodies, vascular and frontotemporal dementia, and hippocampal sclerosis in the Florida State Brain Bank. Alzheimer’s disease and associated disorders vol. 16.4 (2002): 203-12. doi:10.1097/00002093-200210000-00001
me Warr et al. QJ Nucl Med Mol Images; 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
INDICATION AND USE OF THE PRODUCT
DATSCAN is indicated as an adjunct to other diagnostic evaluations for visualization of the striatal dopamine transporter using single photon emission computed tomography (SPECT) brain imaging in adult patients with:
suspected parkinsonian syndromes (PS) or
Suspicion of dementia with Lewy bodies (DLB).
Important Safety Information for DaTscan™ (Ioflupan I 123 Injection)
DaTscan is contraindicated in patients with known severe hypersensitivity to ioflupane I 123.
WARNINGS AND PRECAUTIONS
- Hypersensitive reactions: Hypersensitivity reactions, including dyspnea, edema, rash, erythema, and pruritus, have been reported following DATSCAN administration.
- Thyroid buildup: DaTscan may contain up to 6% free iodide (iodine-123). Thyroid uptake of iodine-123 may result in an increased long-term risk of thyroid neoplasia. To decrease iodine-123 accumulation in the thyroid, block the thyroid gland prior to administration of DaTscan.
Mild to moderate headache, nausea, vertigo, dry mouth, or dizziness were reported in clinical trials. In post-marketing experience, hypersensitivity reactions and pain at the injection site have been reported.
Drugs that bind to the dopamine transporter with high affinity can interfere with DaTscan imaging. The impact of dopamine agonists and antagonists on DaTscan imaging results has not been established.
USE IN SPECIFIC POPULATIONS
- The pregnancy: Radioactive iodine products cross the placenta and can permanently affect fetal thyroid function. Administration of a thyroid-blocking agent is recommended prior to the use of DaTscan in a pregnant woman. All radiopharmaceuticals have the potential to cause fetal harm. There are no data available on the use of DaTscan in pregnant women to assess the drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Inform the pregnant woman of the potential risks of fetal radiation exposure with DaTscan administration
- Lactation: Iodine 123 (I 123), the DaTscan radionuclide, is present in human milk. There is no information on the effects on infants or on milk. Advise a lactating woman to discontinue nursing and express and discard breast milk for at least 6 days after administration of DaTscan to minimize radiation exposure to a nursing infant.
- Pediatric use: The safety and efficacy of DaTscan in pediatric patients have not been established.
- Geriatric use: No differences in responses between elderly and younger patients requiring dose adjustment were observed in the parkinsonian syndrome studies.
- Renal insufficiency: DaTscan is excreted by the kidney and patients with severe renal impairment may have increased radiation exposure and abnormalities on DaTscan images.
The risks of overdose are predominantly related to increased radiation exposure, with long-term risks of neoplasia. In case of radioactivity overdose, frequent urination and defecation should be recommended to minimize the patient’s exposure to radiation.
PROCEDURE — Radiological Safety
DaTscan emits radiation and must be handled safely to minimize radiation exposure to clinical staff and patients.
Before administration of DaTscan, read the prescription information for additional Important Security Information.
To report SUSPECTED ADVERSE REACTIONS, contact GE Healthcare at 800 654 0118 (option 2, then option 1) or FDA at 800 FDA 1088 orr www.fda.gov/medwatch.
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 complementary radiopharmaceutical imaging agent to help clinicians 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 the world’s leading innovator of medical technology, pharmaceutical diagnostics and digital solutions, GE Healthcare enables clinicians to make faster, more informed decisions through smart devices, data analytics, applications and services, underpinned by its Edison intelligence platform. With more than 100 years of experience in the healthcare industry and around 48,000 employees worldwide, the company operates at the center of an ecosystem working towards precision healthcare, digitizing healthcare, helping drive the productivity and improve outcomes for patients, providers, health systems and researchers around the world.