Eli Lilly, AstraZeneca Get Fast Track Designation for Alzheimer's Drug

By Denise Roland

AstraZeneca PLC (AZN) said Monday that the Alzheimer's drug it is co-developing with Eli Lilly & Co (LLY) has received fast-track designation from the U.S. Food and Drug Administration, a status designed to speed up the development of promising new medicines.

The drug, dubbed AZD3293, is part of a hot new class of Alzheimer's drugs called BACE inhibitors which act to prevent the formation of a substance known as amyloid, whose build up in the brain is thought to be the main cause of the degenerative disease.

The FDA awards fast-track status to drugs it believes could fulfil an unmet need in a serious condition. It means AstraZeneca will have increased access to officials at the agency while developing the drug, in order to minimize delays.

Earlier this year AstraZeneca and Lilly said they would progress the drug to the final stage of testing in patients with early stage Alzheimer's.

They also plan to start testing the drug in patients with mild Alzheimer's in a separate trial.

BACE inhibitors are the latest glimmer of hope in a field dogged by failures, but they could stumble in later-stage development. Eli Lilly scrapped a BACE inhibitor, LY2886721, in 2013 over concerns that the drug could affect liver function.

Write to Denise Roland at [e-mail]

(END) Dow Jones Newswires

August 22, 2016 07:04 ET (11:04 GMT)

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