Investigational Alzheimer’s Drug Gets FDA Fast Track

Amyloid plaque
Amyloid plaque
The drug will also be the subject of a second phase 3 study evaluating the safety and efficacy in patients with mild Alzheimer's dementia.

The US Food and Drug Administration (FDA) has granted Fast Track Designation for AZD3293, Eli Lilly and Co. and AstraZeneca’s investigational beta secretase cleaving enzyme (BACE) inhibitor for the treatment of early Alzheimer’s disease.

The drug, which is currently in phase 3 clinical trials, has been shown to reduce beta-amyloid in the cerebrospinal fluid of people with Alzheimer’s disease and healthy controls.  By inhibiting BACE, the drug is intended to prevent or slow the formation and accumulation of amyloid plaque in the brain, in turn preventing or slowing the progression of the neurodegenerative disease.

“BACE inhibitors have the potential to transform the treatment of Alzheimer’s disease, one of the biggest challenges facing medical science today,” Craig Shering, project lead for AZD3293 at AstraZeneca, said in a statement.

The drug is currently being evaluated in the phase 2/3 AMARANTH study, in which patients with probable Alzheimer’s disease or mild cognitive impairment are randomly assigned to receive either the study drug or placebo for 2 years. The Lilly/AstraZeneca Alliance also announced the launch of a second phase 3 study, DAYBREAK-ALZ, which recently began recruiting patients. The trial will evaluate the safety and efficacy of AZD3293 in patients with mild Alzheimer’s dementia.


Lilly and AstraZeneca receive FDA Fast Track designation for AZD3293, an investigational treatment for early Alzheimer’s disease [press release]. Indianapolis, Indiana: Eli Lilly and Company Newsroom; August 22, 2016.