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Lilly and AstraZeneca Receive FDA Fast Track Designation for AZD3293, an Investigational Treatment for Early Alzheimer's Disease

INDIANAPOLIS, Aug. 22, 2016 /PRNewswire/ -- Eli Lilly and Company (LLY) and AstraZeneca today announced they have received U.S. Food and Drug Administration (FDA) Fast Track designation for the development program in Alzheimer's disease for AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in phase 3 clinical trials. The FDA's Fast Track program is designed to expedite the development and review of new therapies to treat serious conditions and tackle key unmet medical needs.

"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 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...


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