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Biogen says U.S. FTC probing Alzheimer’s disease drug -Breaking

by Mike Robinson

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© Reuters. FILEPHOTO: This sign is marking a Biogen facility located in Cambridge (Massachusetts), U.S. January 26, 2017. REUTERS/Brian Snyder/File Photo

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(Reuters] – A U.S. antitrust regulator asked Biogen Inc. to submit documents regarding the marketing approval for its Alzheimer’s drug treatment. The filing was made by the drugmaker.

Biogen’s annual report for 2014 stated that the U.S. Federal Trade Commission sent it a civil investigative request, which is similar to a subpoena.

Biogen also said that the U.S. Securities and Exchange Commission has inquired about Aduhelm. A controversial approval was granted last year.

In June, the U.S. Food and Drug Administration approved Biogen’s Aduhelm. However, a panel made up of expert advisors voted against it. This led to several panel members being forced out and U.S. legislators launching an investigation.

Aduhelm’s sales are now stagnant as there is uncertainty about coverage by the U.S. Medicare plan for seniors 65+, who are the ones most at risk of developing Alzheimer’s.

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