FDA approves Amyvid
The US FDA has approved Eli Lilly’s Amyvid, a diagnostic imaging agent that is intended to help diagnose Alzheimer’s disease.
Amyvid is a radioactive imaging agent that binds to beta-amyloid plaques and causes them to show up on positron emission tomography, or PET, scans of the patient’s brain. It does not prove that a patient with cognitive problems has Alzheimer’s disease nor does it completely rule out the condition. Eli Lilly says Amyvid is one tool intended to help find the cause of a patient’s mental decline.
‘It's estimated that one in five patients clinically diagnosed with probable Alzheimer's disease during life do not end up having Alzheimer's disease pathology upon autopsy,’ said Daniel Skovronsky, president and ceo of Avid, and global brand development leader for Amyvid at Lilly.
‘The approval of Amyvid offers physicians a tool that, in conjunction with other diagnostic evaluations, can provide information to help physicians evaluate their patients.’
The FDA refused to approve Amyvid in March 2011, stating that Eli Lilly needed to create a programme to help make sure scans using Amyvid would be interpreted correctly.
Eli Lilly bought Avid Radiopharmaceuticals, the developer of Amyvid, for $300m in 2010.
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