On January 20, an FDA advisory committee will give its opinion on whether to approve Eli Lilly’s radiological tracer that promises to revolutionise Alzheimer’s disease diagnosis.
True diagnosis of the disease is currently only achievable from a post-mortem biopsy of the brain. The Indianapolis giant thinks florbetapir F18 (18F-AV-45) has the potential to spot specific disease signatures via brain scan, and crucially in early stages. Expert panelists are likely to scrutinise whether results of a patient’s brain scan truly correlate with the incidence of those disease biomarkers observed in an autopsy; data so far, while not perfect, have shown significant promise. Lilly’s recent $800m acquisition of Avid Radiopharmaceuticals was mainly geared at harnessing the value of the diagnostic. If approved, the agent holds significant deal value for Avid’s shareholders, and an important complimentary tool to Lilly’s pivotal Alzheimer’s candidate, solanezumab.