Brain Plaque Diagnostic PET Imaging Agent Receives Approval

In 2011, Eli Lilly (Indianapolis, IN, USA) was unsuccessful in gaining the US Food and Drug Administration’s (FDA) approval to use its radioactive diagnostic agent Amyvid (Florbetapir F-18 injection) for diagnosis of Alzheimer’s disease (AD) in patients. In the second attempt, it has finally obtained a positive regulatory approval, but for a more general indication.

The company announced in April 2012 that the FDA approved the agent for use with positron emission tomography (PET) imaging scans to identify beta-amyloid plaque in a living patient’s brain. Targeted patients can be suspected of having Alzheimer’s or other causes of cognitive decline. Lilly subsidiary Avid Radiopharmaceuticals (Philadelphia, PA, USA), the developer of the diagnostic agent, cautioned, however, that its new product will aid in AD diagnoses, but is not a definitive tool because the plaque can also be involved in other conditions. Physicians typically do not know for sure if a patient has AD until after the patient dies and they perform an autopsy.

“It’s estimated that one in five patients clinically diagnosed with probably Alzheimer’s disease during life do not end up having Alzheimer’s disease pathology upon autopsy,” Avid president and CEO Daniel Skovronsky said in a statement. “The approval …offers physicians a tool that, in conjunction with other diagnostic evaluations, can provide information to help physicians evaluate their patients.”

The hope is that the diagnostic will help identify the amyloid presence earlier, and subsequently determine more rapidly if a patient likely has AD. Then, physicians could begin treatments earlier in the deteriorating process.

The contrast agent binds to the beta amyloid, and physicians can then see it light up during a PET scan. The FDA rejected the initial approval application over concerns that physicians could have trouble interpreting the plaque scans. Since then, the company has developed a more detailed training program.

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Avid Radiopharmaceuticals