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EDITOR´S PICK: REUTERS: U.S. FDA extends review period for Biogen’s Alzheimer’s drug to June

(Reuters) – Biogen Inc and partner Eisai Co Ltd said on Friday the U.S. Food and Drug Administration has extended the review period for their experimental Alzheimer’s disease treatment by three months from March.

Biogen’s shares rose about 10% as the FDA extension raised some hopes that the drug may still be approved despite a panel of experts to the FDA voting against it in November.

“Our key takeaway is that if the FDA would have wanted to reject the drug, we would have heard the decision by now,” said Truist analyst Robyn Karnauskas.

An FDA approval would make the drug, aducanumab, the first new treatment for Alzheimer’s in decades and the first that appears to be able to slow progression of the fatal, mind-wasting condition that affects millions of people.


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