Eisai Plunges as Alzheimer Drug Fails to Get FDA Panel Approval
Eisai Plunges as Alzheimer Drug Fails to Get FDA Panel Approval
(Bloomberg) -- Shares in Japanese drugmaker Eisai Co. plunged the most on record after the Alzheimer’s therapy it is developing with Biogen Inc. failed to gain support from a panel of U.S. Food and Drug Administration advisers on Friday.
The outside experts voted 8 to 1, with 2 undecided, that data from a single clinical trial with positive results was insufficient to show the drug works. They also voted 10 to 0, with 1 undecided, that the positive study shouldn’t be considered primary proof the drug works in light of conflicting evidence from a different trial.
Eisai’s shares sank as much as 26%, to the lowest level since May, in early trading in Tokyo on Monday. Shares of Biogen were halted throughout the regular trading day on Friday.
The votes contradict a report FDA reviewers prepared ahead of the meeting that supported the efficacy of the drug, called aducanumab, though there was dissent in the agency. That news sent Eisai shares up 18% on Thursday. The stock is down almost 5% for the year.
The FDA will continue the review process with a decision by March.
Approval of Biogen’s therapy would be a milestone for the long battle against Alzheimer’s, a harrowing brain-wasting disease that affects some 5.8 million Americans. While there are other drugs that temporarily improve some symptoms, none slow or stop the eventually lethal destruction of brain neurons, the Alzheimer’s Association said in a report last year.
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