AstraZeneca, Lilly Receive Fast Track Designation For Alzheimer’s DrugBy
AstraZeneca and Eli Lilly and Company have received US Food and Drug Administration (FDA) fast track designation for AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in Phase III clinical trial for Alzheimer's disease.
AstraZeneca and Lilly formed an alliance in 2014 for the development and commercialization of AZD3293. Under the agreement, Lilly leads clinical development, working with researchers from AstraZeneca's neuroscience research and development team. AstraZeneca is responsible for manufacturing. The companies will take joint responsibility for commercialization of the molecule and will share all future costs equally for development and commercialization as well as net global revenues post-launch.
In addition to a continuing Phase II/III study, AstraZeneca and Lilly have also announced the planned initiation of a second Phase III trial for AZD3293 in people with mild Alzheimer's dementia, and began enrolling participants in the third quarter of 2016.