Lily's Amyvid Approved in EU for Patients with Cognitive Impairment Being Evaluated for Alzheimer's

Eli Lilly and Company (NYSE: LLY)and Avid Radiopharmaceuticals, Inc., a wholly owned subsidiary of Lilly,announced today that Amyvid (Florbetapir F 18 Injection) has receivedmarketing authorization from the European Commission as a diagnosticradiopharmaceutical indicated for Positron Emission Tomography (PET) imagingof beta-amyloid neuritic plaque density in the brains of adult patients withcognitive impairment who are being evaluated for Alzheimer's disease and othercauses of cognitive impairment. Amyvid should be used in conjunction with aclinical evaluation.[1]Alzheimer's Disease is one of many possible causes of cognitive impairment,which can make diagnosis challenging.[2],[3] Alzheimer's Disease and othercauses of cognitive impairment share many overlapping symptoms, includingdeficiencies in memory, visuospatial ability, executive function, behavior,and language.[2],[3]  It is estimated that up to one in five patientsclinically diagnosed with probable Alzheimer's Disease during life do notexhibit Alzheimer's Disease pathology upon autopsy.[4],[5]"We believe that Amyvid fills an unmet need in the medical community,providing physicians with important information about the presence or absenceof beta-amyloid plaques that can help identify the cause of their patients'cognitive symptoms," said Diane Bakaysa, Amyvid global brand developmentleader. "This is important because, if, based on negative Amyvid findings andclinical assessment, it is determined that Alzheimer's Disease is not thecause of cognitive impairment, a physician can avoid unnecessary orpotentially harmful treatments associated with a misdiagnosis of Alzheimer'sDisease."[6],[7],[8]Beginning in Q2 2013, Amyvid will be available in select areas within theEuropean Union.Amyvid for intravenous use was approved by the U.S. Food and DrugAdministration (FDA) in April 2012 and is supplied in 10 mL, 30 mL, or 50 mLmultidose vials containing 500–1,900 MBq/mL Florbetapir F 18.[9]  Amyvid isindicated for PET imaging of the brain to estimate beta-amyloid neuriticplaque density in adult patients with cognitive impairment who are beingevaluated for Alzheimer's Disease (AD) and other causes of cognitivedecline.[9]A negative Amyvid scan indicates sparse to no neuritic plaques and isinconsistent with a neuropathological diagnosis of AD at the time of imageacquisition; a negative scan result reduces the likelihood that a patient'scognitive impairment is due to AD. A positive Amyvid scan indicates moderateto frequent amyloid neuritic plaques; neuropathological examination has shownthis amount of amyloid neuritic plaque is present in patients with AD, but mayalso be present in patients with other types of neurologic conditions as wellas older people with normal cognition.[9]Amyvid is an adjunct to other diagnostic evaluations. A positive Amyvid scandoes not establish a diagnosis of AD or other cognitive disorder. Safety andeffectiveness of Amyvid have not been established for predicting developmentof dementia or other neurologic condition, or monitoring responses totherapies.[9]