Historic FDA approval for Alzheimer's treatment

7 June 2021

Marking a landmark decision, the US Food and Drug Administration today approved the first new treatment for Alzheimer’s disease in nearly two decades.

The much-anticipated approval of the Biologics License Application (BLA) was for Biogen’s (Nasdaq: BIIB) aducanumab as the first treatment to address an underlying cause of Alzheimer's disease despite controversy over mixed clinical trial results for the drug, a negative advisory panel vote in November last year and the FDA extended the review period by three months in January this year.

Biogen’s shares rose 4.1% to $298.00 pre-market, but trading in the stock was halted pending the announcement. It eventually closed up 34% at $395.85 having hit more than $450.

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