Biogen's Alzheimer's Therapy Granted FDA Fast-Track Status
02 September 2016 - 9:40AM
Dow Jones News
Biogen Inc. said its investigational therapy for the early stage
of Alzheimer's disease was granted fast-track designation by the
U.S. Food and Drug Administration, a designation intended to bring
promising drugs for serious conditions to market faster.
The Cambridge, Mass., biotechnology company's shares rose 1.3%
to $310 in recent after-hours trading.
The drug—called aducanumab—is designed to help clear the brain
of beta amyloid plaques, which many scientists say play a role in
causing Alzheimer's, a progressive, memory-destroying condition
associated with older age.
The treatment is in late-stage clinical trials to assess the
safety and effectiveness of the treatment in slowing cognitive
decline in patients with early and mild forms of Alzheimer's
disease.
The company plans to provide more details regarding its clinical
studies of aducanumab at coming medical meetings.
Biogen dominates the lucrative market for multiple sclerosis
drugs. Its Tecfidera treatment for the condition had one of the
best new-drug launches after its 2013 approval. The company, which
is searching for a new chief executive, is spinning off its
faster-growing but small hemophilia-drugs unit, to narrow its focus
on neurological disorders.
Last month, AstraZeneca PLC said the Alzheimer's drug it is
codeveloping with Eli Lilly & Co. received FDA fast-track
designation. 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.
Write to Tess Stynes at tess.stynes@wsj.com
(END) Dow Jones Newswires
September 01, 2016 19:25 ET (23:25 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
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