FDA Approves DaTscan for Dementia with Lewy Bodies

GE Healthcare recently announced the U.S. Food and Drug Administration (FDA) granted marketing approval for its imaging agent, DaTscan, for use in people with suspected dementia with Lewy bodies (DLB). DaTscan is an agent used during imaging scan called single photon emission computed tomography or SPECT and can help differentiate between DLB, Alzheimer’s disease and other forms of dementia.

DLB can mimic Alzheimer’s disease and is missed as a diagnosis in up to 70% of dementia cases. Yet, DLB affects one in five living people living with dementia, making it the second most common type of progressive dementia after Alzheimer’s disease.

An early diagnosis of DLB can help people to receive proper treatment and receive the proper education that is critical for both the person diagnosed and their care partner. Without an accurate diagnosis, individuals are at risk for being treated with medications not appropriate for DLB, and cannot find the information, resources and support they need.

DaTscan has been approved by the European Union for years for DLB, but until now had been previously approved by the FDA to differentiate between essential tremor and Parkinson’s disease.