FDA officials this month announced that the agency approved GE Healthcare’s (NYSE:GE) Vizamyl radiopharmaceutical for use in combination with PET imaging to help diagnose patients with Alzheimer’s disease and dementia.
Vizamyl is only the 2nd drug with FDA indication to help detect abnormal build-up of beta amyloid proteins in the brain, and the 1st with indication for visual interpretation of colored images, rather than only black and white.
Excess concentrations of beta amyloid protein in the brain is a key diagnostic feature of Alzheimer’s disease, causing impaired cognitive functions such as diminishing motor skills, memory, judgment and other symptoms.
"Many Americans are evaluated every year to determine the cause of diminishing neurologic functions, such as memory and judgment, that raise the possibility of Alzheimer’s disease," FDA Center for Drug Evaluation & Research deputy director Dr. Shaw Chen said in prepared remarks. "Imaging drugs like Vizamyl provide physicians with important tools to help evaluate patients for AD and dementia."
The FDA win was based on a pair of clinical trials with 761 total patient participants, which demonstrated that the "Vizamyl correctly detects beta amyloid in the brain," and that the scans produced with Vizamyl are reproducible and translatable by trained readers, according to the FDA notice.
GE Healthcare expects next year to begin commercially offering color-image PET imaging with Vizamyl, according to a company statement.
The only other imaging agency with FDA approval for the detection of beta amyloids in diagnosis of Alzheimer’s is Eli Lilly’s (NYSE:LLY) Amyvid, which won FDA approval last year and has since struggled to get wider reimbursement from the Centers for Medicare & Medicaid Services.