GE Healthcare’s (NYSE:GE) newly FDA-approved Vizamyl imaging agent is about to make its initial appearance in 7 U.S. markets, where doctors can use it to help diagnose patients with Alzheimer’s disease and dementia.
Vizamyl is only the 2nd FDA-approved drug for detecting the abnormal buildup of beta amyloid proteins in the brain, a key indicator of Alzheimer’s disease. Vizamyl is also the 1st drug approved for visual interpretation of color images, rather than in black and white.
GE plans late in the 2nd quarter to offer the agent to imaging centers in: East Rutherford, N.J; Woburn, Mass.; Beltsville, Md.; East Lansing, Mich.; Dallas, Texas; Phoenix, Ariz.; and Colton, Calif.
"The commercial availability of Vizamyl and rollout of the electronic training program represent our commitment to helping physicians deliver more accurate and timely assessments of patients with cognitive disorders," GE Healthcare Life Sciences PET Neurology director Ben Newton said in prepared remarks. ""The ability to detect or exclude the presence of beta amyloid plaques in the brain may help physicians make more accurate assessments of patients with suspected cognitive disorders, including AD."
GE in October won the FDA nod to market the Vizamyl agent in detection of Alzheimer’s disease and dementia, with approval based on a pair of clinical trials with 761 total patient participants. Those studies 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.
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.