Biogen Prepares to Resubmit Request for FDA Approval of Alzheimer’s Drug


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Alzheimer’s and other dementias challenge researchers to search for ways to diagnose, treat and eventually cure — if not prevent — the disease.

Biogen Inc. has announced it will seek regulatory approval from the Food and Drug Administration (FDA) for its medication, aducanumab, which failed its clinical trials in March this year, sending the price of its shares crashing.

A new analysis of more data from the failed clinical trials, however, showed that the therapy did in fact help Alzheimer’s patients’ cognitive function and their ability to perform basic tasks, the company said. Biogen CEO Michel Vounatsos told Bloomberg the firm made the decision to resubmit the application early next year after he met with the FDA on Monday.


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The company, which is based in Cambridge, Massachusetts, added in its statement that it is developing the treatment in partnership with the Eisai Company of Japan after getting “clear support from the FDA.”

The drug targets beta amyloid, a protein that forms clumps of plaque in the brain and is thought to be a cause of the disease. It appears to reduce the levels of the plaques, but only slows progression of the disease; it does not cure Alzheimer’s, the company said.

Biogen stocks have jumped as much as 42 percent, to $318, approaching the price at which the stock was trading before it plunged in March after the announcement of the failure of its clinical trial.


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