Eli Lilly and Avid Radiopharmaceuticals, a wholly owned subsidiary of Lilly, have received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in Europe, recommending approval of Amyvid (Florbetapir F-18) solution for injection as a diagnostic radiopharmaceutical indicated for 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 positive opinion is now referred for final action to the European Commission, which has the authority to approve medicines for the European Union (EU). The commission usually decides on CHMP recommendations within three months.
Amyvid for intravenous use was approved by the FDA in April and is supplied in 10 mL, 30 mL or 50 mL multidose vials containing 500-1900 MBq/mL Florbetapir F-18. Amyvid is a radioactive diagnostic agent indicated for PET imaging of the brain to estimate beta-amyloid neuritic plaque density in patients with cognitive impairment who are being evaluated for Alzheimer's disease and other causes of cognitive decline.
A negative Amyvid scan indicates sparse to no amyloid plaques are currently present, which is inconsistent with a neuropathological diagnosis of Alzheimer's disease and reduces the likelihood that a patient's cognitive impairment is due to Alzheimer's disease, according to Indianapolis-based Eli Lilly. A positive Amyvid scan indicates moderate to frequent amyloid plaques are present; this amount of amyloid plaque is present in patients with Alzheimer's disease, but also may be present in patients with other types of neurologic conditions and in older people with normal cognition.
The company added that it's "important to note" that Amyvid is an adjunct to other diagnostic evaluations. "A positive Amyvid scan does not establish a diagnosis of Alzheimer's disease or other cognitive disorder," the company said in a release. "Additionally, the safety and effectiveness of Amyvid have not been established for predicting development of dementia or other neurologic condition, or monitoring responses to therapies."