Curium, the world’s leading nuclear medicine company, announced today that it intends to submit updated labeling to the U.S. Food and Drug Administration (FDA) for its generic version of DaTscan™ (Ioflupane I 123 Injection) to include a new indication and updated safety information. The additional indication will be to assist in the evaluation of adult patients for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging with suspected dementia with Lewy bodies (DLB). Curium intends to match the labeling recently approved by the FDA for GE Healthcare’s DaTscan on November 3, 2022 as generic drugs are required to have the same labeling as the reference listed drug (DaTscan). Curium will update Ioflupane I 123 Injection important risk information to include the new safety information at the time of labeling implementation. Ioflupane I 123 Injection is a SPECT brain imaging agent used to assist in the evaluation of adult patients with suspected Parkinsonian syndromes.
Approximately one in five patients with dementia suffers from DLB, making it the second most common form of degenerative dementia after Alzheimer’s Disease1. 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 Disease2. The expected new indication enables clinicians to use Ioflupane I 123 Injection 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 future3.
Ed Porter, North American Vice President of Regulatory and Medical at Curium commented: «Ioflupane I 123 Injection continues to be an important tool when evaluating the complex set of diseases considered Parkinsonian syndromes. Curium has years of experience in this disease state as our Ioflupane I 123 Injection product in Europe launched with this indication. We intend to leverage that experience in the US to continue our efforts on making an everyday impact on patients and their families.”
DaTscan™ is a registered trademark of GE Healthcare Limited.
References:
1、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
2 、Warr et al. Q J Nucl Med Mol Imaging; 2012; 56: 39-54
3、Zweig and Galvin Alzheimer’s Research & Therapy 2014, 6.21; https://alzres.biomedcentral.com/articles/10.1186/alzrt251
About Ioflupane I 123 Injection
INDICATIONS AND USAGE
Ioflupane I 123 Injection is a radiopharmaceutical indicated for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging to assist in the evaluation of adult patients with suspected Parkinsonian syndromes (PS). In these patients, Ioflupane I 123 Injection may be used to help differentiate essential tremor from tremor due to PS (idiopathic Parkinson’s disease, multiple system atrophy and progressive supranuclear palsy). Ioflupane I 123 Injection is an adjunct to other diagnostic evaluations.
Ioflupane I 123 Injection was not designed to distinguish among PD, MSA, and PSP. The effectiveness of Ioflupane I 123 Injection as a screening or confirmatory test and for monitoring disease progression or response to therapy has not been established.
