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Lilly, AstraZeneca get fast track OK for Alzheimers drug

Delaware Business Daily - 8/24/2016

AstraZeneca and Eli Lilly and Company (Lilly) today announced they have received US Food and Drug Administration Fast Track designation for the development program for AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in Phase III clinical trial.

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. AZD is an Alzheimer's disease drug.

Craig Shering, AZD3293 Project Lead in Global Medicines Development at AstraZeneca, said: "The Fast Track Designation in the US for this promising potential therapy reinforces the ambition of the AstraZeneca-Lilly BACE Alliance to 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."

In addition to the continuing AMARANTH Phase II/III study, AstraZeneca and Lilly also announced the planned initiation of a second Phase III trial for AZD3293. The trial, called DAYBREAK-ALZ, studies of AZD3293 in people with mild Alzheimer's dementia, and began enrolling participants in the third quarter of this year

AZD3293 has been shown in studies to reduce levels of amyloid beta in the cerebrospinal fluid of people with Alzheimer's and healthy volunteers. The progression of Alzheimer's disease is characterised by the accumulation of amyloid plaque in the brain.

The drug could slow down Alzheimer's.

AstraZeneca employs about 2,000 in Delaware.

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