Biogen seeks FDA approval for drug targeting Alzheimer's disease

By Nicholas Sakelaris

Oct. 22 (UPI) -- Pharmaceutical company Biogen said Tuesday it's seeking regulatory approval for a drug it believes could revolutionize treatments for Alzheimer's disease.

The company announced it will file early next year with the Food and Drug Administration for approval of its drug aducanumab.


Biogen discontinued clinical studies for the drug early this year after data showed it wasn't as effective as researchers expected. A new analysis of a larger data set, Biogen said, showed more promise and "reduced clinical decline" in Alzheimer's patients.

Alzheimer's affects about 50 million people worldwide and there are no approved therapies.

"Today's announcement is truly heartening in the fight against Alzheimer's," Biogen CEO Michel Vounatsos said in a statement. "We are hopeful about the prospect of offering patients the first therapy to reduce the clinical decline of Alzheimer's disease."

Biogen said it will offer aducanumab to patients enrolled in existing clinical studies.

Shares of Biogen climbed by 30 percent Tuesday on news of the filing.

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