FDA expands indications for neuroimaging radiotracer
GE Healthcare’s DaTscan (ioflupane I 123) has already been used to diagnose more than 1 million patients with suspected Parkinson’s disease, and now the radiopharmaceutical can be applied when symptoms point to the second most common form of degenerative dementia (after only Alzheimer’s disease).
That would be dementia with Lewy bodies (DLB, also known as LBD for Lewy body dementia).
Used with SPECT, the newly FDA-approved indication helps neuroradiologists visualize dopamine transporters (DaT) in the brains of adult patients experiencing cognitive falloff.
GE says the DLB application is effective at distinguishing the condition from other dementias, including Alzheimer’s, with which many DBL patients are misdiagnosed.
Approximately 1 in 5 patients with dementia have DLB, and only Alzheimer’s strikes more frequently.
GE Healthcare’s announcement quotes James Galvin, MD, MPH, a consulting neurologist with the University of Miami Miller School of Medicine.
“The label expansion for DaTscan moves patients a step closer to an earlier, more accurate diagnosis,” Galvin says. “[This] is beneficial for them and their families, setting them on the right treatment path sooner and helping to avoid medications and treatments that could be potentially harmful.”
GE Healthcare notes the approval follows its announced plan of earlier this year to “bolster its molecular imaging neurology portfolio by complementing DaTscan with two pipeline radiopharmaceuticals”—one for PET and another for SPECT.
Full announcement here.
Dave P. has worked in journalism, marketing and public relations for more than 30 years, frequently concentrating on hospitals, healthcare technology and Catholic communications. He has also specialized in fundraising communications, ghostwriting for CEOs of local, national and global charities, nonprofits and foundations.