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.
![Overview of the study design. (A) The fully automated deep learning framework was developed to estimate body composition (BC) (defined as subcutaneous adipose tissue [SAT] in liters; visceral adipose tissue [VAT] in liters; skeletal muscle [SM] in liters; SM fat fraction [SMFF] as a percentage; and intramuscular adipose tissue [IMAT] in deciliters) from MRI. The fully automated framework comprised one model (model 1) to quantify different BC measures (SAT, VAT, SM, SMFF, and IMAT) as three-dimensional (3D) measures from whole-body MRI scans. The second model (model 2) was trained to identify standardized anatomic landmarks along the craniocaudal body axis (z coordinate field), which allowed for subdividing the whole-body measures into different subregions typically examined on clinical routine MRI scans (chest, abdomen, and pelvis). (B) BC was quantified from whole-body MRI in over 66,000 individuals from two large population-based cohort studies, the UK Biobank (UKB) (36,317 individuals) and the German National Cohort (NAKO) (30,291 individuals). Bar graphs show age distribution by sex and cohort. BMI = body mass index. (C) After the performance assessment of the fully automated framework, the change in BC measures, distributions, and profiles across age decades were investigated. Age-, sex-, and height-adjusted body composition reference curves were calculated and made publicly available in a web-based z-score calculator (https://circ-ml.github.io).](https://img.auntminnieeurope.com/mindful/smg/workspaces/default/uploads/2026/05/body-comp.XgAjTfPj1W.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
