Eli Lilly and Co. (LLY: Quote) and Avid Radiopharmaceuticals, Inc., a wholly owned subsidiary of Lilly, announced that Amyvid (Florbetapir F 18 Injection) has received marketing authorization from the European Commission as a diagnostic radiopharmaceutical indicated for Positron Emission Tomography or PET imaging of beta-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive impairment. Amyvid should be used in conjunction with a clinical evaluation, the company said.
Alzheimer’s Disease is one of many possible causes of cognitive impairment, which can make diagnosis challenging.
The company said that beginning in the second-quarter 2013, Amyvid will be available in select areas within the European Union.
Amyvid for intravenous use was approved by the U.S. Food and Drug Administration or FDA in April 2012 and is supplied in 10 mL, 30 mL, or 50 mL multidose vials containing 500-1,900 MBq/mL Florbetapir F 18. Amyvid is indicated for PET imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease or AD and other causes of cognitive decline.
Amyvid is a radioactive diagnostic agent that is injected into the bloodstream, where it crosses the blood-brain barrier and selectively binds to amyloid plaques.
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by RTT Staff Writer
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