FDA Staffers Uncertain About Experimental Parkinson’s Disease Imaging Drug

It is unclear how well an experimental drug being developed by GE Healthcare would help improve the ability of doctors to diagnose Parkinson’s disease, according to a Food and Drug Administration staff memo.

GE has asked the FDA to approve the injectable drug, called DaTSCAN, for use in brain scans to help detect the loss of certain brain neurons. The company has not asked for FDA approval of the drug to diagnose specific diseases or conditions, but DaTSCAN already is approved in Europe and a total of 32 countries around the world.

FDA staffers say data on the effectiveness of the radioactive drug is “unclear” and that the company’s clinical studies “are inconsistent with the type of design and conduct usually anticipated” for imaging agents.

Because the company-sponsored studies did not determine how the imaging drug would work with imaging scans, the FDA cannot determine how well the proposed drug would work, if at all, the memo said, according to a Reuters Health report.

Advisory Panel Meets Next Week

A panel of medical experts who advise the FDA on proposed new drugs is set to consider GE’s request for DaTSCAN next week. The panel is expected to consider whether the benefits of the drug are worth its possible side effects, including headache, nausea and dizziness, and make a recommendation on whether the FDA should give the imaging drug the go-ahead. While the FDA is not required to follow the advice of its advisory panels, it most often does.

DaTSCAN uses a combination of radioactive iodine and ioflupane, a molecule that binds with the dopamine transporters in the brain. It is used along with single photon emission computed tomography (SPECT) imaging in patients who show symptoms of Parkinson’s or other disorders, such as dementia and palsy.

A lack of dopaminergic neurons, which provide dopamine to the brain and are critical for the central nervous system, often trigger the disorders.

“DaTSCAN would benefit patients and physicians in the USA by helping to improve the … diagnosis of both movement disorders and dementias,” the company said in a statement.

No related posts.