Eli Lilly, AstraZeneca receive FDA clearance for Alzheimer’s treatment

Eli Lilly and Company and AstraZeneca have received U.S. FDA Fast Track designation for AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor for Alzheimer’s that is currently in phase 3 clinical trials.

AZD3293 has been proven in studies to reduce the level of amyloid beta in the cerebro-spinal fluid for people with Alzheimer's as well as in healthy participants. The BACE enzyme is known to be a key factor in the development of amyloid beta, the plaque in the brain that causes Alzheimer’s. By stopping the production of amyloid beta, the progression of the disease is slowed.

"We are pleased the FDA places a high priority on the development of drugs that target Alzheimer's disease, one of the most critical health issues of our time," said Phyllis Ferrell, vice president and global development leader for Alzheimer's disease at Eli Lilly. "Most importantly, this is a positive step forward for the millions of patients, families, caregivers, advocates and healthcare providers who fight every day for progress."

"The Fast Track designation in the U.S. for this promising potential therapy reinforces the ambition of the AstraZeneca-Lilly BACE alliance to help advance science for patients and their families managing this devastating illness," said Craig Shering, AZD3293 Project Lead in Global Medicines Development at AstraZeneca. "BACE inhibitors have the potential to transform the treatment of Alzheimer's disease, one of the biggest challenges facing medical science today."

The two companies also announced the start of the second phase 3 trial for AZD3293, the trial will test the safety and efficiency of the blocker in those with mild Alzheimer's dementia.