Amyvid radiopharmaceutical has received approval in the European Union for use in patients with cognitive impairment being evaluated for Alzheimer’s disease.
Eli Lilly and Company and Avid Radiopharmaceuticals, a whole owned subsidiary of Lilly, announced the European Commission marketing authorization of Amyvid (Florbetapir F 18 injection) as a radiopharmaceutical indicated for PET imaging of beta amyloid plaque in the brains of patients with cognitive impairment.
Amyvid was approved by the FDA in April 2012. It will be available in select areas in the European Union beginning in the second quarter of this year.
A negative Amyvid scan indicates little to no amyloid plaques and is inconsistent with a diagnosis of Alzheimer’s disease. A negative scan reduces the likelihood that a patient’s cognitive impairment is due to Alzheimer’s, the company said. A positive Amyvid scan does not establish a diagnosis of Alzheimer’s or other cognitive disorder.
“We believe that Amyvid fills an unmet need in the medical community, providing physicians with important information about the presence or absence of beta-amyloid plaques that can help identify the cause of their patients’ cognitive symptoms,” Diane Bakaysa, Amyvid global brand development leader, said in a release. “This is important because, if, based on negative Amyvid findings and clinical assessment, it is determined that Alzheimer’s Disease is not the cause of cognitive impairment, a physician can avoid unnecessary or potentially harmful treatments associated with a misdiagnosis of Alzheimer’s Disease.”