Eli Lilly and its subsidiary Avid Radiopharmaceuticals have received approval from the European Commission for their Amyvid (florbetapir F-18) radiopharmaceutical.
Amyvid has been approved for injection as a diagnostic radiopharmaceutical for PET imaging of beta-amyloid 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 is scheduled for release in select areas within the European Union beginning in the second quarter. In the meantime, Lilly plans to pursue reimbursement options in the European market.
The next big event for Amyvid will be on January 30: The U.S. Centers for Medicare and Medicaid Services' (CMS) Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) is scheduled to hold a meeting to review policies regarding coverage of PET studies of beta amyloid in the brain.
Medicare currently does not cover beta-amyloid PET imaging, although Amyvid received clearance from the U.S. Food and Drug Administration (FDA) in April of last year.
