Vizamyl Clinical Development

A timeline chronicling the development history of GE Healthcare’s Flutemetamol F 18 and the regulatory path of radioactive diagnostic agents for PET imaging of the brain to estimate beta amyloid neuritic plaque density.

Vizamyl Clinical Development
Date	Action
IND Chronology (#101-866)
5/19/2008	Pre-IND meeting
10/23/2008	Seminal meeting of the Peripheral and Central Nervous System Advisory Committee to discuss the validation and clinical utility of amyloid imaging agents in Alzheimer’s disease patients, specifically Lilly’s Amyvid, GE’s Vizamyl and BAY 94-9172, a Bayer Healthcare candidate now licensed to Indian drug maker Piramal
3/26/2009	Type C meeting to discuss GE’s clinical development plan
9/7/2010	End-of-Phase II meeting, including discussion of GE’s proposed training program for image interpretation
1/20/2011	Advisory committee meeting to discuss Amyvid approval considerations underscores FDA’s unease over the state of reader training and consistency of scan interpretations
3/17/2011	“Complete response” letter issued for Amyvid, requiring a training program be developed to teach PET scan readers how to accurately and consistently read the scans and that the readings of the images be comparable in reliability to that of an autopsy
4/6/2012	Amyvid approval
4/12/2012	Pre-NDA meeting
NDA Chronology (#203-137)
10/26/2012	NDA submission
2/14/2013	Proposed proprietary name Vizamyl accepted
4/9/2013	Mid-cycle clinical review communication
7/28/2013	Late-cycle clinical review communication
10/26/2013	Vizamyl approval