FDA Approvals of 2012

9 of 39


Drug: Amyvid
Generic molecule: florbetapir F18
Company: Avid Radiopharmaceuticals
Approval date: April 6

The scoop: When Eli Lilly ($LLY) picked up Amyvid in its $800 million acquisition of Avid Radiopharmaceuticals, it surely planned to pair up this brain dye, which is used for ruling out Alzheimer's disease, with the treatment that it has been trying to move forward. But while it got a qualified approval for the dye, its two late-stage trials for Alzheimer's candidate solanezumab crashed and burned this summer. The test measures brain plaque buildup but the troublesome issues surrounding the potential for misdiagnosis led an expert committee as well as the FDA to reject Lilly's Amyvid early last year. Being careful not to oversell it at this point, Lilly says Amyvid is one tool docs can use to evaluate patients.