Eli Lilly, AstraZeneca Get Fast Track Designation for Alzheimer's Drug
August 22 2016 - 7:19AM
Dow Jones News
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 denise.roland@wsj.com
(END) Dow Jones Newswires
August 22, 2016 07:04 ET (11:04 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
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