FDA grants GE SPECT agent priority review
The FDA has accepted GE Healthcare's new drug application (NDA) for DaTSCAN (Ioflupane I123 Injection) for priority review.
GE said that the SPECT imaging radiopharmaceutical is intended to be used to help detect the loss of functional nigrostraiatal dopaminergic neurons in patients presenting with symptoms or signs of dopaminergic neurodegeneration.
DaTSCAN has been available in Europe since 2000, where it is indicated for use in patients with clinically uncertain Parkinsonian Syndromes to help differentiate essential tremor from Parkinsonian syndromes related to idiopathic Parkinson's Disease (PD), multiple system atrophy (MSA) and Progressive Supranuclear Palsy (PSP).
DaTSCAN is unable to discriminate between PD, MSA and PSP, according to GE. In Europe, it is also indicated to help differentiate probable dementia with Lewy bodies (DLB) from Alzheimer's disease; it is unable to discriminate between DLB and Parkinson's disease dementia, the company said.
GE said that the SPECT imaging radiopharmaceutical is intended to be used to help detect the loss of functional nigrostraiatal dopaminergic neurons in patients presenting with symptoms or signs of dopaminergic neurodegeneration.
DaTSCAN has been available in Europe since 2000, where it is indicated for use in patients with clinically uncertain Parkinsonian Syndromes to help differentiate essential tremor from Parkinsonian syndromes related to idiopathic Parkinson's Disease (PD), multiple system atrophy (MSA) and Progressive Supranuclear Palsy (PSP).
DaTSCAN is unable to discriminate between PD, MSA and PSP, according to GE. In Europe, it is also indicated to help differentiate probable dementia with Lewy bodies (DLB) from Alzheimer's disease; it is unable to discriminate between DLB and Parkinson's disease dementia, the company said.