|GE Healthcare is on the verge of European approval for its Alzheimer's imaging agent.--Courtesy of GE Healthcare|
GE Healthcare's ($GE) imaging agent Vizamyl is on the verge of European approval as a tool to help diagnose Alzheimer's disease, something that could help counter challenges to build momentum for the product in the U.S.
The med tech arm of the global conglomerate General Electric disclosed that Vizamyl earned a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP. In short, the regulators recommend marketing approval for the imaging agent for use with a PET scanner to help spot β-amyloid buildup in the brains of adult patients being evaluated for Alzheimer's or other neurodegenerative conditions. Such a recommendation is a good sign that the product is likely to gain an EU regulatory nod.
Similar to U.S. approval conditions, the European recommendation is that Vizamyl be used only in conjunction with a clinical evaluation. As in the U.S., GE Healthcare is careful in its announcement of the EU approval recommendation for Vizamyl to note that it is not an Alzheimer's diagnostic tool on its own.
"While Vizamyl does not establish a diagnosis for Alzheimer's Disease or other cognitive disorders, it is a useful tool in conjunction with a clinical evaluation, and may have the potential to lead to earlier diagnosis and intervention in the future," the company said in its announcement.
In April, GE Healthcare began to roll out Vizamyl in the U.S., following FDA approval last October. But the product may be slow to take off domestically, due, in part, to reimbursement uncertainty and its limited approval for use only in conjunction with other tests in the quest for an Alzheimer's diagnosis. By the end of June, GE expected to launch Vizamyl at 7 imaging centers across the U.S. and also train physicians on how to use it.
GE is also seeking to broaden Vizamyl's use in other ways. The company outlicensed Vizamyl to Merck ($MRK) and Eisai to help both as they develop Alzheimer's treatments that target the amyloid proteins. The quest to develop viable Alzheimer's drugs has been a tough battle, but if they succeed, Vizamyl could generate revenue as a companion diagnostic.
Imaging agents designed to help screen for Alzheimer's are not without their challenges. Eli Lilly ($LLY), for example, won similar, limited U.S. FDA approval for its β-amyloid imaging agent Amyvid, and it is the first company to reach that milestone. But Medicare won't reimburse its use in most indications beyond clinical trials.
The CHMP issued its positive opinion on Vizamyl after a review of a number of clinical trials. Several Phase III brain autopsy and biopsy studies supplied much of that data, GE Healthcare said, all of which showed that Vizamyl worked well in identifying β-amyloid plaque with both a high sensitivity and specificity.
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