Lilly and AstraZeneca announce AZD3293 Fast Track designation from FDA

Eli Lilly and AstraZeneca recently released a joint announcement revealing that the two companies have received Fast Track designation for the AZD3293 Alzheimer’s disease development program from the U.S. Food and Drug Administration (FDA).

AZD3293 is an oral beta secretase cleaving enzyme (BACE) inhibitor that is undergoing Phase 3 clinical trials.

"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," Lilly VP and Global Development Leader for Alzheimer’s Phyllis Ferrell said. "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."

The Fast Track program was developed by the FDA to expedite development and reviews for new therapies.

"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," AstraZeneca AZD3293 Project Lead in Global Medicines Development Craig Shering said. "BACE inhibitors have the potential to transform the treatment of Alzheimer's disease, one of the biggest challenges facing medical science today."