Investigational Alzheimer's Treatment Receives FDA Fast Track Designation

The FDA has granted Fast Track designation to Lilly and AstraZeneca’s investigational treatment for Alzheimer’s disease.

AZD3293 is an oral beta secretase cleaving enzyme (BACE) inhibitor currently in phase 3 clinical trials, though the Fast Track designation may expedite its development and FDA review. Because BACE is associated with the development of amyloid beta, inhibiting this enzyme is expected to prevent the formation and build-up of amyloid plaque in the brain, which in turn may help slow the progression of Alzheimer’s disease.

“BACE inhibitors have the potential to transform the treatment of Alzheimer’s disease, one of the biggest challenges facing medical science today,” stated Craig Shering, AZD3293 project lead in global medicines development at AstraZeneca, in a press release.

Thus far, AZD3293 has been shown to reduce levels of amyloid beta in cerebrospinal fluid in patients with Alzheimer’s and healthy volunteers.

Lilly and AstraZeneca will continue the AMARANTH phase 2/3 study, and they are also planning to start a second DAYBREAK-ALZ phase 3 trial for AZD3293, which will examine the drug’s safety and efficacy in patients with mild Alzheimer’s dementia. Enrollment will begin in the third quarter of 2016.

“We are pleased the FDA places a high priority on the development of drugs that target Alzheimer’s disease,” stated Phyllis Ferrell, vice president and global development leader for Alzheimer’s disease at Lilly, in the press release. “Most importantly, this is a positive step forward for the millions of patients, families, caregivers, advocates and health care providers who fight every day for progress.”