The Peripheral and Central Nervous System Drugs committee has voted to recommend DaTSCAN (Ioflupane I123 Injection) to the FDA. The panel Tuesday determined that DaTSCAN has a favorable risk to benefit profile, voting 11 to two with one abstention.
The proposed indication for DaTSCAN is for the visualization of the dopamine transporter (DaT) distribution within the striata by SPECT in patients presenting with symptoms or signs suggestive of dopaminergic neurodegeneration, GE said.
In May, the FDA accepted the new drug application, granting DaTSCAN priority review. If approved, DaTSCAN will be the first radiopharmaceutical agent available to detect DaT distribution within the brain, according to the company.
The Prescription Drug User Fee Act (PDUFA) date for DaTSCAN is Sept. 9.
The radiopharmaceutical agent 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, multiple system atrophy and Progressive Supranuclear Palsy.