Aug 22, 2016
Eli Lilly and Company and AstraZeneca have announced that they have received Fast Track designation from U.S. Food and Drug Administration (FDA) for the development program in Alzheimer’s disease for AZD3293. It is an oral beta secretase cleaving enzyme (BACE) inhibitor currently in phase 3 clinical trials. The Fast Track program of FDA is designed to expedite the development and review of new therapies for treating serious conditions and tackle key unmet medical needs.
Phyllis Ferrell, vice president and global development leader for Alzheimer’s disease at Lilly, said: “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. 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. BACE inhibitors have the potential to transform the treatment of Alzheimer’s disease, one of the biggest challenges facing medical science today,” said Craig Shering, AZD3293 Project Lead in Global Medicines Development at AstraZeneca.