Biogen's Alzheimer's Therapy Granted FDA Fast-Track Status

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 [e-mail]

(END) Dow Jones Newswires

September 01, 2016 19:25 ET (23:25 GMT)

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