GE Healthcare ($GE) has at long last nailed down FDA approval for an imaging agent designed to help evaluate living patients for Alzheimer's disease or dementia. It's the second brain-imaging drug of its kind to gain U.S. regulators' OK, and plans call for rolling it out commercially in 2014.
Vizamyl (flutemetamol) is approved specifically for use in PET imaging of the brain to help evaluate the buildup of beta amyloid plaque. Specifically, it latches onto beta amyloid, which is widely believed to be a sign of Alzheimer's. GE touts Vizamyl as the only PET imaging tracer approved for visual interpretation of color images.
In April 2012, Eli Lilly ($LLY) became the first company to obtain the FDA's sign-off to use a radioactive diagnostic agent (Amyvid) with PET scans to detect beta-amyloid plaque in a live patient's brain. Eli Lilly had wanted it approved specifically as an Alzheimer's imaging tool. Typically, an autopsy has been the only definitive way to verify if a patient definitely has Alzheimer's versus some other form of dementia. Navidea ($NAVB) is also developing a similar agent.
The FDA itself announced Vizamyl's approval, an action it typically saves for devices and drugs that set a new healthcare precedent. Regulators, in their announcement, noted approval limits for Vizamyl: It can't predict the development of Alzheimer's disease or monitor how patients respond to a given Alzheimer's treatment.
Vizamyl's approval follows two successful clinical studies involving 384 patients, and GE established its safety in 761 patients, regulators noted.
Kieran Murphy, President and CEO of GE Healthcare Life Sciences, said in a statement that the company sees Vizamyl as aiding the quest for viable Alzheimer's drug treatments.
"We hope that Vizamyl will help advance treatment options by helping to enroll the right people into the right clinical trials, which may lead to disease-modifying medications," he said.
Toward that end, GE Healthcare licensed the agent to Merck ($MRK) in 2012 for use on select trial participants for MK-8931, Merk's hoped-for Alzheimer's blockbuster drug.
Insurance reimbursement may be a challenge, however. The Centers for Medicare and Medicaid Services (CMS) earlier this fall declined to cover the use of PET scans to detect beta-amyloid buildup in dementia patients. In a narrow ruling, CMS said it would cover the procedure to rule out Alzheimer's disease in diagnoses that are clinically difficult and narrowly defined, and to select patients for clinical trials.
- here's the FDA's announcement
- check out GE's release