GE-DATSCAN (Ioflupane I 123 Injection) indication expanded to include use in patients with suspected dementia with Lewy bodies (DLB)

GE-DATSCAN (Ioflupane I 123 Injection) indication expanded to include use in patients with suspected dementia with Lewy bodies (DLB)

DaTscan is the first radiopharmaceutical diagnostic tracer approved by U.S FDA for use in patients with suspected dementia with Lewy bodies (DLB).

Builds on DaTscan’s global market leadership with over one million doses already used worldwide in the clinical evaluation of Parkinson’s syndromes

One in five dementia patients suffer from DLB, the second most common form of degenerative dementia after Alzheimer’s disease

GE Healthcare DaTscan has been approved by the US Food and Drug Administration FDA approved 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 for more patients, including those with suspected DLB, at 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 diseaseii. 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 futureiii.

About one in five dementia patients suffer from DLB, making it the second most common form of degenerative dementia after Alzheimer’s disease.

Professor James E GalvinMD, MPH, Consultant, University of Miami Miller School of Medicine, U.SHe said: ‘Misdiagnosis is a major problem for those patients with suspected dementia with Lewy bodies, causing incalculable anxiety for the patient and family, as well as putting the patient at potentially higher risk of adverse events due to the delay in 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 .

hibberd markmedical director of GE Healthcare Pharmaceutical DiagnosticsHe said: ‘More than a 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 MCI.”

Approval of DaTscan for use in DLB is the culmination of significant work, including clinical trials, data collection and analysis, and evidence collation for submission to the U.S FDA, all proving GE Healthcare continued commitment and investment in this space.

At the beginning of this year, GE health announced plans to strengthen 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 investigation, a broader variety of diagnostic markers to help evaluate adult patients with suspected parkinsonian syndromes.

GE Healthcare Pharmaceutical Diagnosis unit is a world leader in imaging agents used to support around 100 million procedures per year worldwide, which equates 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.

References:

i Barker, Warren W et al. ‘Relative frequencies of Alzheimer’s disease, Lewy bodies, vascular and frontotemporal dementia and hippocampal sclerosis in the State of Florida Brain Bank.’ Alzheimer’s disease and associated disorders vol. 16.4 (2002): 203-12. doi:10.1097/00002093-200210000-00001

ii Warr et al. QJ Nucl Med Mol Images; 2012; 56: 39-54

iii Zweig and Galvin Alzheimer’s Research and 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 syndrome (PS) or suspected dementia with Lewy bodies (DLB).

Important Safety Information for DaTscan (Ioflupan I 123 Injection)

CONTRAINDICATIONS

DaTscan is contraindicated in patients with known severe hypersensitivity to ioflupane I 123.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions: Hypersensitivity reactions, including dyspnea, edema, rash, erythema, and pruritus, have been reported following administration of DATSCAN.

Thyroid Accumulation: 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.

ADVERSE REACTIONS

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.

DRUG INTERACTIONS

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

Pregnancy: Radioactive iodine products cross the placenta and may 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 radionuclide in DaTscan, 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 Impairment: DaTscan is excreted by the kidney and patients with severe renal impairment may have increased radiation exposure and altered DaTscan images.

OVERDOSE

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.

Prior to DaTscan administration, please read the full Prescribing Information for additional information.

Important Security Information.

To report SUSPECTED ADVERSE REACTIONS, contact GE health 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 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.

On GE health:

GE health is he $17.7 billion health business GE (NYSE: GE). As a world leading innovator in medical technology, pharmaceutical diagnostics and digital solutions, GE health enables clinicians to make faster, more informed decisions through smart devices, data analytics, apps 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.

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Media Contact:

Debbie Leven

Debbie.Leven@ge.com

+44 7785 456999

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