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Windlesham, UK & Indianapolis, USA – Eli Lilly and Company 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 facing medical science today.”
In addition to the continuing AMARANTH phase 2/3 study, Lilly and AstraZeneca have also announced the planned initiation of a second phase 3 trial for AZD3293. The trial, called DAYBREAK-ALZ, studies the safety and efficacy of AZD3293 in people with mild Alzheimer’s dementia and began enrolling participants in the third quarter of 2016.
AZD3293 has been shown in studies to reduce levels of amyloid beta in the cerebro-spinal fluid of people with Alzheimer’s and healthy volunteers. The progression of Alzheimer’s disease is characterized by the accumulation of amyloid plaque in the brain. BACE is an enzyme associated with the development of amyloid beta. Inhibiting BACE is expected to prevent the formation and build-up of amyloid plaque which in turn may help slow the progression of the disease.